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| Name | Class |
|---|---|
| Atopic Dermatitis Research Network | OTHER |
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The purpose of this study is to examine the safety and effectiveness of a new therapy, commensal lotion containing infection fighting bacteria, on decreasing or eliminating the infection causing bacteria found on the skin of Atopic Dermatitis (AD) patients.
This study will enroll adult participants, 18-60 years of age, with moderate-to-severe atopic dermatitis (AD) and a positive Staphylococcus aureus (S. aureus) colonized lesion (at least 15 cm^2 in size) on the upper extremities.
Participants who are eligible based on their positive Staph culture results will be randomized to one of two treatments: Targeted Microbiome Transplant Lotion (TMT) or Placebo (2:1 randomization). One lesional site measuring at least 15 cm^2 and one non-lesional site of equal size will be identified on the participant's ventral upper extremities as the target swabbing areas. These sites will be photographed and marked for swabbing for reference at the participant's future visits. Participants will be instructed to apply investigational product with gloved hands to their ventral upper extremities bilaterally from the wrist to the upper humerus, which will include the identified lesional and non-lesional swabbing sites twice a day for 1 week starting on Day 0. Participants will return to clinic on Day 4 for the assessment of adverse events, the collection of skin swabs from the identified target sites, and to obtain additional investigational product and gloves. Participants will complete an additional clinic visit on Day 7 to correspond with the end of their 1 week treatment. During this visit, participants will be assessed for AEs and provide skin swab samples. All unused product and empty packets will be returned during the Day 4 and Day 7 visits. Three additional clinic visits on Days 8, 9, and 11 will be scheduled for additional skin swabs to assess the safety and the stability of the microbiome transplant and time to recurrence of Staph colonization. Participants will be followed through Day 38 to assess for safety and disease status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMT Lotion | Experimental | The targeted microbiome transplant (TMT) lotion will be provided in single-dose sealed packets. The lotion should be stored at 4°Celsius (=39.2 degrees Fahrenheit). Participants randomized to active TMT will apply 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
|
| Placebo Lotion | Placebo Comparator | Placebo lotion will be provided in single-dose sealed packets. The lotion should be stored at 4°Celsius (=39.2 degrees Fahrenheit). Participants randomized to placebo will apply 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMT Lotion | Biological | TMT product and Vegetable glycerin-Cetaphil® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Per-Participant Daily Event Rate: Serious and Non-Serious Treatment Emergent Adverse Events (TEAEs) | Per-participant daily event rate of TEAEs was calculated as the number of events per-participant-days at risk. Statistical method employed: Poisson generalized linear model with a log link function and including the natural log of the number of days active in the study during Day 0 to Day 8. | Day 0 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The Occurrence of at Least One Serious or Non-Serious Treatment Emergent Adverse Event (TEAE) | The number of participants for which at least one treatment emergent adverse event (AE), defined as an increase in grade from baseline or from the last post-baseline value that does not meet grading criteria, was reported during the measure time frame. | Day 0 (after initiation of study treatment) through Day 8 (last day of study treatment) |
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Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
Participant must be able to understand and provide informed consent;
Fulfills the Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria (Appendix A) for active Atopic Dermatitis (AD);
A Staphylococcus aureus (S. aureus) positive culture colonized lesion, at least 15 cm^2 in size, located on a ventral upper extremity (e.g., arm);
An Investigator Global Assessment (IGA) score, on the ventral arms, of at least moderate severity;
A body surface area (BSA), as measured by Mosteller BSA Calculator, between 1.26 m^2 (e.g., 4 feet, 10 inches and 85 pounds [38.6 Kg] and 2.25 m^2 (e.g., 6 feet, 3 inches and 210 pounds [95.5 Kg]; and
Females of childbearing potential who are willing to use adequate contraception 30 days prior to the Screening Visit and until participation in the study is complete.
--Females of childbearing potential must agree to use an acceptable method of birth control (e.g. total abstinence, oral contraceptives, intrauterine device [IUD], barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera, Norplant, NuvaRing, or hormonal implants) for the duration of study participation.
Male participants who are willing to use an acceptable method of contraception (e.g. barrier methods with spermicide, surgical sterilization or surgically sterilized partner) or practice abstinence until participation in the study is complete.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Gallo, M.D., Ph.D. | University of California, San Diego: Dermatology Clinical Trials Unit | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Diego | San Diego | California | 92122 | United States | ||
| National Jewish Health General Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33619370 | Derived | Nakatsuji T, Hata TR, Tong Y, Cheng JY, Shafiq F, Butcher AM, Salem SS, Brinton SL, Rudman Spergel AK, Johnson K, Jepson B, Calatroni A, David G, Ramirez-Gama M, Taylor P, Leung DYM, Gallo RL. Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial. Nat Med. 2021 Apr;27(4):700-709. doi: 10.1038/s41591-021-01256-2. Epub 2021 Feb 22. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Disease (NIAID) Website | View source |
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Screened S. aureus positive participants requiring medication/therapy washout of ≤14 days to meet inclusion/exclusion criteria were randomized within 14 days of screening. Screened S. aureus positive participants requiring medication/therapy washout > 14 days, completed a Repeat Culture Visit after a washout, to confirm S. aureus colonization.
Recruitment of patients with active atopic dermatitis took place between 20 September 2017 through 24 April 2019 at 2 clinical centers in the US: National Jewish Health: Division of Pediatric Allergy and Clinical Immunology and University of California - San Diego
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| ID | Title | Description |
|---|---|---|
| FG000 | TMT Lotion | The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets. Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
| FG001 | Placebo Lotion | Placebo lotion was provided in single-dose sealed packets. Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants randomized and received at least one treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | TMT Lotion | The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets. Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Per-Participant Daily Event Rate: Serious and Non-Serious Treatment Emergent Adverse Events (TEAEs) | Per-participant daily event rate of TEAEs was calculated as the number of events per-participant-days at risk. Statistical method employed: Poisson generalized linear model with a log link function and including the natural log of the number of days active in the study during Day 0 to Day 8. | Safety sample: All participants who were randomized and received any doses of their assigned intervention. | Posted | Least Squares Mean | 95% Confidence Interval | events per-participant-day | Day 0 to Day 8 |
|
8 days
Adverse Events (AEs) grade 1 or higher.
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Targeted Microbiome Transplant (TMT) | The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets. Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2019 | Mar 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2019 | Mar 17, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D014145 | Trail Making Test |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| Placebo Lotion | Drug | Cetaphil® moisturizing lotion and vegetable glycerin |
|
|
| Per-Participant Daily Event Rate of Serious and Non-Serious Adverse Events (AEs) | Per-participant daily event rate of serious and non-serious AEs was calculated by the number of events per-participant days active in the study during Screening to Day 38. | Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation) |
| The Occurrence of at Least One Serious or Non-Serious Adverse Event (AE) | The number of participants for which at least one adverse event (AE) was reported | Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation) |
| The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame | The eczema area and severity index (EASI) for the ventral arms is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-18. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, papulation, excoriation, and lichenification each scored on a scale of 0 (absent) to 3 (severe) for the ventral arms. The component measuring area is the percent area of the ventral arms with atopic dermatitis lesions scored on a scale of 0 (0%) to 6 (90-100%). | Days 0, 4, 7, 8 and 11 |
| The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame | SCORAD (Severity scoring of Atopic Dermatitis) is a composite severity index comprising A) the amount/extent of body surface area affected; A= 0-100%, B) disease intensity assessed as sum of scores for 6 parameters (erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness), each graded from 0 (none) to 3 (severe); B= 0-18, and C) subjective symptom visual analog assessments for pruritus [0 (no itch) to 10 (worst imaginable itch)] and sleep loss [0 (no sleep loss) to 10 (worst imaginable sleep loss)] summed for a total symptom score; C=0-20. The SCORAD = A/5 + 7B/2 + C and ranges from 0 (no AD present) to 103 (severe). | Days 0, 4, 7, 8 and 11 |
| The Rajka-Langeland (RL) Score at Specific Days During the Measure Time Frame | The Rajka & Langeland (RL) eczema severity score is a simple assessment of AD severity as well as the classification of AD into mild, moderate, or severe. The score is based on the grading of: (i) eczema extent based on % body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale from 1-3, and the scores are summed. The RL score ranges from 3 to 9 (mild, 3-4; moderate, 4.5-7.5; severe, 8-9) | Days 0 and 7 |
| The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame | The pruritus visual analog scale (VAS) asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0 to 10 (0 = no itch, 10 = worst imaginable itch) | Days 0, 4, 7, 8 and 11 |
| The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Days 0, 4, 7, 8 and 11 |
| The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS on lesional and non-lesional skin measured by qPCR relative colony forming units per centimeter squared [rCFU/cm^2] | At days 0, 4, 7, 8 and 11 |
| The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Change From Baseline Levels of Coagulase-Negative Staphylococcus (CoNS) Bacteria Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared [rCFU/cm^2]) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. hominis A9 present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared [rCFU/cm^2]) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S.aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of combined S. hominis present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of combined Staphylococci present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of combined bacteria present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
| Denver |
| Colorado |
| 80206 |
| United States |
| Placebo Lotion |
Placebo lotion was provided in single-dose sealed packets. Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Age Continuous (years) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Screening Staphylococcus aureus (S. aureus) blood agar growth score | Measure of S. aureus colonies present on the participant's lesional skin, as measured by bacteria growth on a blood agar plate. A skin swab sample was collected from an area of lesional skin on the participant's upper extremity at their Screening Visit. Growth was measured as 0-4, increasing in relation to the amount of S. aureus present on the blood agar plate. In order to enroll, participants needed a positive S. aureus colonized lesion, with a growth score of at least 1. | Count of Participants | Participants |
|
| OG001 | Placebo Lotion | Placebo lotion was provided in single-dose sealed packets. Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. |
|
|
|
| Secondary | The Occurrence of at Least One Serious or Non-Serious Treatment Emergent Adverse Event (TEAE) | The number of participants for which at least one treatment emergent adverse event (AE), defined as an increase in grade from baseline or from the last post-baseline value that does not meet grading criteria, was reported during the measure time frame. | Safety sample: All participants who were randomized and received any doses of their assigned intervention. | Posted | Count of Participants | Participants | Day 0 (after initiation of study treatment) through Day 8 (last day of study treatment) |
|
|
|
|
| Secondary | Per-Participant Daily Event Rate of Serious and Non-Serious Adverse Events (AEs) | Per-participant daily event rate of serious and non-serious AEs was calculated by the number of events per-participant days active in the study during Screening to Day 38. | Safety sample (all participants who are randomized and receive any amount of study drug) | Posted | Least Squares Mean | 95% Confidence Interval | events per-participant-day | Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation) |
|
|
|
|
| Secondary | The Occurrence of at Least One Serious or Non-Serious Adverse Event (AE) | The number of participants for which at least one adverse event (AE) was reported | Safety sample (all participants who are randomized and receive any amount of study drug) | Posted | Count of Participants | Participants | Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation) |
|
|
|
|
| Secondary | The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame | The eczema area and severity index (EASI) for the ventral arms is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-18. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, papulation, excoriation, and lichenification each scored on a scale of 0 (absent) to 3 (severe) for the ventral arms. The component measuring area is the percent area of the ventral arms with atopic dermatitis lesions scored on a scale of 0 (0%) to 6 (90-100%). | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Mean | Standard Deviation | units on a scale | Days 0, 4, 7, 8 and 11 |
|
|
|
| Secondary | The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame | SCORAD (Severity scoring of Atopic Dermatitis) is a composite severity index comprising A) the amount/extent of body surface area affected; A= 0-100%, B) disease intensity assessed as sum of scores for 6 parameters (erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness), each graded from 0 (none) to 3 (severe); B= 0-18, and C) subjective symptom visual analog assessments for pruritus [0 (no itch) to 10 (worst imaginable itch)] and sleep loss [0 (no sleep loss) to 10 (worst imaginable sleep loss)] summed for a total symptom score; C=0-20. The SCORAD = A/5 + 7B/2 + C and ranges from 0 (no AD present) to 103 (severe). | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Mean | Standard Deviation | units on a scale | Days 0, 4, 7, 8 and 11 |
|
|
|
| Secondary | The Rajka-Langeland (RL) Score at Specific Days During the Measure Time Frame | The Rajka & Langeland (RL) eczema severity score is a simple assessment of AD severity as well as the classification of AD into mild, moderate, or severe. The score is based on the grading of: (i) eczema extent based on % body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale from 1-3, and the scores are summed. The RL score ranges from 3 to 9 (mild, 3-4; moderate, 4.5-7.5; severe, 8-9) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Mean | Standard Deviation | units on a scale | Days 0 and 7 |
|
|
|
| Secondary | The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame | The pruritus visual analog scale (VAS) asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0 to 10 (0 = no itch, 10 = worst imaginable itch) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Mean | Standard Deviation | units on a scale | Days 0, 4, 7, 8 and 11 |
|
|
|
| Secondary | The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | CFU/cm^2 | Days 0, 4, 7, 8 and 11 |
|
|
|
|
| Secondary | The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS on lesional and non-lesional skin measured by qPCR relative colony forming units per centimeter squared [rCFU/cm^2] | Data were not collected. | Posted | At days 0, 4, 7, 8 and 11 |
|
|
| Secondary | The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | CFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
|
|
|
|
| Secondary | The Change From Baseline Levels of Coagulase-Negative Staphylococcus (CoNS) Bacteria Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of CoNS present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared [rCFU/cm^2]) | Data were not collected. | Posted | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
|
|
| Secondary | The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. hominis A9 present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared [rCFU/cm^2]) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
|
|
|
|
| Secondary | The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | CFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
|
|
|
|
| Secondary | The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
|
|
|
|
| Secondary | The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | CFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
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|
|
|
| Secondary | The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S.aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
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|
|
|
| Secondary | The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | CFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
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|
|
|
| Secondary | The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group | Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
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| Secondary | The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of combined S. hominis present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
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|
|
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| Secondary | The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of combined Staphylococci present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
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|
|
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| Secondary | The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately | Amount of combined bacteria present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2) | Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | rCFU/cm^2 | Days 0 (1 hour post treatment), 4, 7, 8 and 11 |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 21 |
| 36 |
| EG001 | Placebo Lotion | Placebo lotion was provided in single-dose sealed packets. Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week. | 0 | 18 | 0 | 18 | 16 | 18 |
| Peripheral swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Day 4 |
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| Day 7 |
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| Day 8 |
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| Day 11 |
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| Day 4 |
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| Day 7 |
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| Day 8 |
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| Day 11 |
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| Day 4 |
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| Day 7 |
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| Day 8 |
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| Day 11 |
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| Day 4 - Lesional |
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| Day 4 - Non-lesional |
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| Day 7 - Lesional |
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| Day 7 - Non-lesional |
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| Day 8 - Lesional |
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| Day 8 - Non-lesional |
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| Day 11 - Lesional |
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| Day 11 - Non-Lesional |
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| Superiority |
| Lesional vs. Non-lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.319 | Geometric mean ratio (GMR) | 0.41 | 2-Sided | 95 | 0.069 | 2.393 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.978 | Geometric mean ratio (GMR) | 1.02 | 2-Sided | 95 | 0.174 | 6.027 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.177 | Geometric mean ratio (GMR) | 3.44 | 2-Sided | 95 | 0.570 | 20.749 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.558 | Geometric mean ratio (GMR) | 1.70 | 2-Sided | 95 | 0.288 | 9.973 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.977 | Geometric mean ratio (GMR) | 1.04 | 2-Sided | 95 | 0.082 | 13.151 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.007 | Geometric mean ratio (GMR) | 33.86 | 2-Sided | 95 | 2.672 | 429.219 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.055 | Geometric mean ratio (GMR) | 11.97 | 2-Sided | 95 | 0.945 | 151.752 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.957 | Geometric mean ratio (GMR) | 0.93 | 2-Sided | 95 | 0.062 | 13.875 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.654 | Geometric mean ratio (GMR) | 1.78 | 2-Sided | 95 | 0.141 | 22.607 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
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| Day 4 - Non-lesional |
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| Day 7 - Lesional |
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| Day 7 - Non-lesional |
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| Day 8 - Lesional |
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| Day 8 - Non-lesional |
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| Day 11 - Lesional |
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| Day 11 - Non-Lesional |
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| Superiority |
| Lesional vs. Non-lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.133 | Geometric mean ratio (GMR) | 0.147 | 2-Sided | 95 | 0.0121 | 1.8018 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.437 | Geometric mean ratio (GMR) | 0.371 | 2-Sided | 95 | 0.0304 | 4.5392 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.863 | Geometric mean ratio (GMR) | 1.247 | 2-Sided | 95 | 0.1002 | 15.5231 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.702 | Geometric mean ratio (GMR) | 0.615 | 2-Sided | 95 | 0.0503 | 7.5106 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.675 | Geometric mean ratio (GMR) | 0.465 | 2-Sided | 95 | 0.0128 | 16.8576 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.057 | Geometric mean ratio (GMR) | 32.638 | 2-Sided | 95 | 0.8994 | 1184.4298 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.181 | Geometric mean ratio (GMR) | 11.539 | 2-Sided | 95 | 0.3180 | 418.7586 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.953 | Geometric mean ratio (GMR) | 0.895 | 2-Sided | 95 | 0.0219 | 36.5559 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.767 | Geometric mean ratio (GMR) | 1.719 | 2-Sided | 95 | 0.0474 | 62.3828 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
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| Day 4 - Non-lesional |
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| Day 7 - Lesional |
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| Day 7 - Non-lesional |
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| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
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| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
| Superiority |
| Lesional vs. Non-lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.030 | Geometric mean ratio (GMR) | 2.823 | 2-Sided | 95 | 1.1038 | 7.2210 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.127 | Geometric mean ratio (GMR) | 2.077 | 2-Sided | 95 | 0.8122 | 5.3135 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.623 | Geometric mean ratio (GMR) | 0.789 | 2-Sided | 95 | 0.3065 | 2.0331 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.328 | Geometric mean ratio (GMR) | 0.627 | 2-Sided | 95 | 0.2450 | 1.6028 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.242 | Geometric mean ratio (GMR) | 2.231 | 2-Sided | 95 | 0.5799 | 8.5866 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.321 | Geometric mean ratio (GMR) | 1.977 | 2-Sided | 95 | 0.5137 | 7.6055 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.366 | Geometric mean ratio (GMR) | 1.860 | 2-Sided | 95 | 0.4833 | 7.1564 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.068 | Geometric mean ratio (GMR) | 3.713 | 2-Sided | 95 | 0.9080 | 15.1856 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.130 | Geometric mean ratio (GMR) | 2.858 | 2-Sided | 95 | 0.7328 | 11.1434 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
|
| Day 4 - Non-lesional |
|
| Day 7 - Lesional |
|
| Day 7 - Non-lesional |
|
| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
|
| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
| Superiority |
| TMT vs Placebo on Lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.008 | Geometric mean ratio (GMR) | 0.08 | 2-Sided | 95 | 0.012 | 0.514 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.001 | Geometric mean ratio (GMR) | 0.04 | 2-Sided | 95 | 0.007 | 0.298 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.017 | Geometric mean ratio (GMR) | 0.09 | 2-Sided | 95 | 0.013 | 0.651 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.001 | Geometric mean ratio (GMR) | 0.04 | 2-Sided | 95 | 0.007 | 0.292 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.358 | Geometric mean ratio (GMR) | 2.42 | 2-Sided | 95 | 0.366 | 15.967 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.019 | Geometric mean ratio (GMR) | 0.10 | 2-Sided | 95 | 0.016 | 0.683 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.023 | Geometric mean ratio (GMR) | 0.11 | 2-Sided | 95 | 0.017 | 0.739 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.017 | Geometric mean ratio (GMR) | 0.09 | 2-Sided | 95 | 0.013 | 0.647 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.299 | Geometric mean ratio (GMR) | 0.37 | 2-Sided | 95 | 0.056 | 2.436 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| Day 4 - Lesional |
|
| Day 4 - Non-lesional |
|
| Day 7 - Lesional |
|
| Day 7 - Non-lesional |
|
| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
|
| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.
| TMT vs Placebo on Lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.849 | Geometric mean ratio (GMR) | 0.88 | 2-Sided | 95 | 0.245 | 3.180 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.155 | Geometric mean ratio (GMR) | 0.40 | 2-Sided | 95 | 0.110 | 1.424 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.242 | Geometric mean ratio (GMR) | 0.45 | 2-Sided | 95 | 0.117 | 1.722 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.258 | Geometric mean ratio (GMR) | 0.47 | 2-Sided | 95 | 0.129 | 1.735 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.726 | Geometric mean ratio (GMR) | 1.26 | 2-Sided | 95 | 0.349 | 4.520 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.080 | Geometric mean ratio (GMR) | 0.32 | 2-Sided | 95 | 0.088 | 1.145 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.748 | Geometric mean ratio (GMR) | 0.81 | 2-Sided | 95 | 0.225 | 2.917 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.760 | Geometric mean ratio (GMR) | 1.23 | 2-Sided | 95 | 0.327 | 4.617 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.713 | Geometric mean ratio (GMR) | 0.79 | 2-Sided | 95 | 0.219 | 2.832 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| Day 4 - Lesional |
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| Day 4 - Non-lesional |
|
| Day 7 - Lesional |
|
| Day 7 - Non-lesional |
|
| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
|
| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
| Superiority |
| Lesional vs Non-Lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.131 | Geometric mean ratio (GMR) | 2.58 | 2-Sided | 95 | 0.753 | 8.853 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.210 | Geometric mean ratio (GMR) | 2.20 | 2-Sided | 95 | 0.640 | 7.527 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.031 | Geometric mean ratio (GMR) | 3.98 | 2-Sided | 95 | 1.138 | 13.290 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.429 | Geometric mean ratio (GMR) | 1.64 | 2-Sided | 95 | 0.479 | 5.630 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.010 | Geometric mean ratio (GMR) | 9.26 | 2-Sided | 95 | 1.712 | 50.043 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.150 | Geometric mean ratio (GMR) | 3.45 | 2-Sided | 95 | 0.637 | 18.627 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.048 | Geometric mean ratio (GMR) | 5.47 | 2-Sided | 95 | 1.012 | 29.578 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.130 | Geometric mean ratio (GMR) | 3.98 | 2-Sided | 95 | 0.665 | 23.821 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.002 | Geometric mean ratio (GMR) | 13.74 | 2-Sided | 95 | 2.542 | 74.304 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
|
| Day 4 - Non-lesional |
|
| Day 7 - Lesional |
|
| Day 7 - Non-lesional |
|
| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
|
| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
| Superiority |
| Lesional vs Non-Lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.027 | Geometric mean ratio (GMR) | 2.42 | 2-Sided | 95 | 1.109 | 5.267 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.153 | Geometric mean ratio (GMR) | 1.76 | 2-Sided | 95 | 0.810 | 3.847 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.160 | Geometric mean ratio (GMR) | 1.76 | 2-Sided | 95 | 0.799 | 3.884 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.489 | Geometric mean ratio (GMR) | 1.32 | 2-Sided | 95 | 0.603 | 2.868 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.044 | Geometric mean ratio (GMR) | 3.10 | 2-Sided | 95 | 1.032 | 9.295 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.805 | Geometric mean ratio (GMR) | 0.87 | 2-Sided | 95 | 0.290 | 2.614 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.022 | Geometric mean ratio (GMR) | 3.62 | 2-Sided | 95 | 1.205 | 10.859 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.010 | Geometric mean ratio (GMR) | 4.83 | 2-Sided | 95 | 1.458 | 15.978 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs Non-Lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.169 | Geometric mean ratio (GMR) | 2.19 | 2-Sided | 95 | 0.716 | 6.692 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
|
| Day 4 - Non-lesional |
|
| Day 7 - Lesional |
|
| Day 7 - Non-lesional |
|
| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
|
| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
| Superiority |
| Lesional vs. Non-lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.060 | Geometric mean ratio (GMR) | 0.214 | 2-Sided | 95 | 0.0427 | 1.0702 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.038 | Geometric mean ratio (GMR) | 0.182 | 2-Sided | 95 | 0.0363 | 0.9100 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.179 | Geometric mean ratio (GMR) | 0.329 | 2-Sided | 95 | 0.0650 | 1.6691 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.015 | Geometric mean ratio (GMR) | 0.136 | 2-Sided | 95 | 0.0271 | 0.6805 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.309 | Geometric mean ratio (GMR) | 0.302 | 2-Sided | 95 | 0.0299 | 3.0493 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.401 | Geometric mean ratio (GMR) | 0.372 | 2-Sided | 95 | 0.0369 | 3.7569 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.655 | Geometric mean ratio (GMR) | 0.591 | 2-Sided | 95 | 0.0586 | 5.9658 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.488 | Geometric mean ratio (GMR) | 0.430 | 2-Sided | 95 | 0.0395 | 4.6836 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.737 | Geometric mean ratio (GMR) | 1.485 | 2-Sided | 95 | 0.1471 | 14.9869 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
|
| Day 4 - Non-lesional |
|
| Day 7 - Lesional |
|
| Day 7 - Non-lesional |
|
| Day 8 - Lesional |
|
| Day 8 - Non-lesional |
|
| Day 11 - Lesional |
|
| Day 11 - Non-Lesional |
|
| Superiority |
| Lesional vs. Non-lesional within TMT at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.440 | Geometric mean ratio (GMR) | 0.656 | 2-Sided | 95 | 0.2245 | 1.9178 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.178 | Geometric mean ratio (GMR) | 0.479 | 2-Sided | 95 | 0.1640 | 1.4007 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.180 | Geometric mean ratio (GMR) | 0.478 | 2-Sided | 95 | 0.1624 | 1.4091 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within TMT at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.060 | Geometric mean ratio (GMR) | 0.357 | 2-Sided | 95 | 0.1222 | 1.0441 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 0 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.373 | Geometric mean ratio (GMR) | 0.498 | 2-Sided | 95 | 0.1068 | 2.3188 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.106 | Geometric mean ratio (GMR) | 0.281 | 2-Sided | 95 | 0.0604 | 1.3106 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.843 | Geometric mean ratio (GMR) | 1.168 | 2-Sided | 95 | 0.2507 | 5.4434 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.587 | Geometric mean ratio (GMR) | 1.559 | 2-Sided | 95 | 0.3122 | 7.7818 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Lesional vs. Non-lesional within Placebo at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.661 | Geometric mean ratio (GMR) | 0.707 | 2-Sided | 95 | 0.1495 | 3.3426 | All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator. | Superiority |
| Day 4 - Lesional |
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| Day 4 - Non-lesional |
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| Day 7 - Lesional |
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| Day 7 - Non-lesional |
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| Day 8 - Lesional |
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| Day 8 - Non-lesional |
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| Day 11 - Lesional |
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| Day 11 - Non-Lesional |
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| Superiority |
| TMT vs Placebo on Lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 779.24 | 2-Sided | 95 | 342.093 | 1774.996 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 673.56 | 2-Sided | 95 | 295.697 | 1534.265 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 60.12 | 2-Sided | 95 | 24.920 | 145.027 | Superiority | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. |
| TMT vs Placebo on Lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.002 | Geometric mean ratio (GMR) | 3.79 | 2-Sided | 95 | 1.636 | 8.767 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment) A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 757.38 | 2-Sided | 95 | 331.143 | 1732.242 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 199.71 | 2-Sided | 95 | 87.636 | 455.127 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 508.45 | 2-Sided | 95 | 223.113 | 1158.715 | Superiority | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. |
| TMT vs Placebo on Non-lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 107.86 | 2-Sided | 95 | 45.568 | 255.313 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 16.09 | 2-Sided | 95 | 7.058 | 36.657 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| Day 4 - Lesional |
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| Day 4 - Non-lesional |
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| Day 7 - Lesional |
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| Day 7 - Non-lesional |
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| Day 8 - Lesional |
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| Day 8 - Non-lesional |
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| Day 11 - Lesional |
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| Day 11 - Non-Lesional |
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| Superiority |
| TMT vs Placebo on Lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 35.19 | 2-Sided | 95 | 14.402 | 85.972 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 41.64 | 2-Sided | 95 | 17.043 | 101.739 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.008 | Geometric mean ratio (GMR) | 3.61 | 2-Sided | 95 | 1.395 | 9.330 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.474 | Geometric mean ratio (GMR) | 1.39 | 2-Sided | 95 | 0.561 | 3.458 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment) A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 266.87 | 2-Sided | 95 | 108.860 | 654.231 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 51.07 | 2-Sided | 95 | 20.907 | 124.768 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 74.96 | 2-Sided | 95 | 30.686 | 183.125 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 26.06 | 2-Sided | 95 | 10.262 | 66.169 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.007 | Geometric mean ratio (GMR) | 3.41 | 2-Sided | 95 | 1.397 | 8.338 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| Day 4 - Lesional |
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| Day 4 - Non-lesional |
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| Day 7 - Lesional |
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| Day 7 - Non-lesional |
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| Day 8 - Lesional |
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| Day 8 - Non-lesional |
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| Day 11 - Lesional |
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| Day 11 - Non-Lesional |
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| Superiority |
| TMT vs Placebo on Lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 12.87 | 2-Sided | 95 | 5.463 | 30.317 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 11.46 | 2-Sided | 95 | 4.863 | 26.986 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.058 | Geometric mean ratio (GMR) | 2.42 | 2-Sided | 95 | 0.971 | 6.024 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.526 | Geometric mean ratio (GMR) | 0.75 | 2-Sided | 95 | 0.315 | 1.805 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment) A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 55.53 | 2-Sided | 95 | 23.490 | 131.279 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 4 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 11.78 | 2-Sided | 95 | 5.000 | 27.755 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 7 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 23.17 | 2-Sided | 95 | 9.833 | 54.579 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 8 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | <0.001 | Geometric mean ratio (GMR) | 11.05 | 2-Sided | 95 | 4.516 | 27.052 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |
| TMT vs Placebo on Non-lesional Skin at Day 11 A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model. | Mixed Models Analysis | 0.042 | Geometric mean ratio (GMR) | 2.43 | 2-Sided | 95 | 1.031 | 5.724 | All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator. | Superiority |