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Due to slow recruitment and sponsor request study ended early
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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle gel | Placebo Comparator | Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. |
|
| Atralin gel | Active Comparator | Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vehicle gel | Drug | Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?". | 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa E Maier, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Department of Dermatology | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15389184 | Background | Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033. | |
| 8129410 | Background | Ertl GA, Levine N, Kligman AM. A comparison of the efficacy of topical tretinoin and low-dose oral isotretinoin in rosacea. Arch Dermatol. 1994 Mar;130(3):319-24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Gel | Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. |
| FG001 | Atralin Gel | Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Gel | Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population | Posted | Number | participants | 24 weeks |
|
Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
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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 | Vehicle Gel | Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Hip Osteoarthritis | Surgical and medical procedures | Non-systematic Assessment | Hip Replacement Surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tearing of the eyes | Eye disorders | Non-systematic Assessment |
Early termination of study due to slow recruitment and sponsor request resulted in smaller number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Maier | University of Michigan | 734-936-4192 | maierl@med.umich.edu |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C557522 | Atralin Gel |
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|
| Atralin gel | Drug | Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. |
|
| 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea. | 24 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance. | 24 weeks |
| 2, 6, 12, 18, 24 weeks |
| Photodamage | Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used. | 24 weeks |
| Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea | 2, 6, 12, 18 and 24 weeks |
| Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea | 2, 6, 12, 18 and 24 weeks |
| Signs of Other Rosacea Subtypes: Papulopustular | Signs of other rosacea subtypes includes papulopustular, inflammatory papule count | 2, 6, 12, 18, 24 weeks |
| Molecular Markers of Inflammation | These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa). | 24 weeks |
| Molecular Evidence of Photodamage | These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9). | 24 weeks |
| Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Signs: Telangiectasia | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Signs: Facial Edema | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | 2, 6, 12, 18 weeks |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | 2, 6, 12, 18 weeks |
| Skin Irritation Assessed by Facial Stinging Upon Product Application | 2, 6, 12, 18 weeks |
| Skin Irritation Assessed by Facial Itching Upon Product Application | 2, 6, 12, 18 weeks |
| Skin Irritation Assessed by Facial Burning Upon Product Application | 2, 6, 12, 18 weeks |
| 10473962 | Background | Vienne MP, Ochando N, Borrel MT, Gall Y, Lauze C, Dupuy P. Retinaldehyde alleviates rosacea. Dermatology. 1999;199 Suppl 1:53-6. doi: 10.1159/000051380. |
| Protocol Violation |
|
| Lost to Follow-up |
|
| BG001 | Atralin Gel | Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Atralin Gel |
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. |
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | LOCF, Complete-Case ITT population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Secondary | Quality of Life | The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | LOCF, Complete-Case ITT Population | Posted | Mean | Standard Deviation | units on a scale | 2, 6, 12, 18, 24 weeks |
|
|
|
|
| Secondary | Photodamage | Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Secondary | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 and 24 weeks |
|
|
|
|
| Secondary | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 and 24 weeks |
|
|
|
|
| Secondary | Signs of Other Rosacea Subtypes: Papulopustular | Signs of other rosacea subtypes includes papulopustular, inflammatory papule count | LOCF, Complete-Case ITT Population | Posted | Mean | Standard Deviation | inflammatory papule | 2, 6, 12, 18, 24 weeks |
|
|
|
|
| Secondary | Molecular Markers of Inflammation | These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa). | ITT Population that completed baseline and Week 24 biopsies | Posted | Mean | Standard Deviation | fold change | 24 weeks |
|
|
|
|
| Secondary | Molecular Evidence of Photodamage | These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9). | ITT Population that completed baseline and week 24 biopsies | Posted | Mean | Standard Deviation | fold change | 24 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | LOCF, Complete-Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin | LOCF, Complete-Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?". | LOCF, Complete Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Primary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 24 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Signs: Facial Edema | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | LOCF, Complete-Case ITT Population | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance | LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit. | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Skin Irritation Assessed by Facial Stinging Upon Product Application | LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit. | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Skin Irritation Assessed by Facial Itching Upon Product Application | LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit. | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| Secondary | Skin Irritation Assessed by Facial Burning Upon Product Application | LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit. | Posted | Number | participants | 2, 6, 12, 18 weeks |
|
|
|
|
| 0 |
| 22 |
| 13 |
| 22 |
| EG001 | Atralin Gel | Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. | 1 | 46 | 25 | 46 |
|
| Blurry Vision | Eye disorders | Non-systematic Assessment |
|
| Hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acid GI Reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment | Nasal/Sinus Congestion, Cold, Upper Respiratory Infection |
|
| Stomach Flu | Infections and infestations | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Head Lice | Infections and infestations | Non-systematic Assessment | Exposure to head lice |
|
| Stye | Infections and infestations | Non-systematic Assessment | Stye of upper eyelid |
|
| GI Distress | Infections and infestations | Non-systematic Assessment |
|
| Infection | Injury, poisoning and procedural complications | Non-systematic Assessment | Possible infection of bx |
|
| Back Disc Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Back problem (disc) L leg pain |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | R shoulder tendonitis |
|
| Arthritis Flare | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Arthritis flare L thumb |
|
| Heel Spur | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | L Heel Spur |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Decreased Memory | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety/Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment | Increased hypertension |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Nasal/Sinus Drainage, Congestion, Allergies |
|
| Asthma Flare | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Irritiated Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Facial Irritation, Sunburn |
|
| Eczema/Atopic Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Flare, Development |
|
| Papular Inflammatory Flare | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nail Disease | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Paronychia, Brittle Nails |
|
| Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Inflamed Lesion/Cysts | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Inflamed Cyst, Lesion, Bites, Cold Sores |
|
| Numbness on Tongue | General disorders | Non-systematic Assessment |
|
Not provided
| Moderate |
|
| Severe |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values to address non-normality of data. |
| 0.57 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values to address non-normality of data. | 0.66 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values to address non-normality of data. | 0.38 | No | Superiority or Other |
| Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values to address non-normality of data. | 0.24 | No | Superiority or Other |
| Score of 2, Mild Photo Damage |
|
| Score of 3, Mild Photo Damage, > score of 2 |
|
| Score of 4, Moderate Photo Damage |
|
| Score of 5, Moderate Photo Damage, > score of 4 |
|
| Score of 6, Moderate/Severe Photo Damage |
|
| Score of 7, Severe Photo Damage, < score of 8 |
|
| Score of 8, Severe Photo Damage |
|
| Mild |
|
| Moderate |
|
| Severe |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values |
| 0.62 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea | Wilcoxon (Mann-Whitney) | Wilcoxon rank-sum test with exact p-values | 1.00 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 1.00 | No | Superiority or Other |
| Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.45 | No | Superiority or Other |
| Mild |
|
| Moderate |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.53 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.53 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.53 | No | Superiority or Other |
| Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 1.00 | No | Superiority or Other |
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values to address non-normality of data. |
| 0.41 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values to address non-normality of data. | 0.66 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values to address non-normality of data. | 0.92 | No | Superiority or Other |
| Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values to address non-normality of data. | 0.80 | No | Superiority or Other |
| CXCL12 Fold Change Score |
|
| TNFa Fold Change Score |
|
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.35 |
| No |
| Superiority or Other |
| Group comparisons of CXCL12 at Week 24 visit were made using fold change data. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.68 | No | Superiority or Other |
| Group comparisons of TNFa at Week 24 visit were made using fold change data. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.76 | No | Superiority or Other |
| MMP1 Fold Change Score |
|
| MMP3 Fold Change Score |
|
| MMP9 Fold Change Score |
|
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.25 |
| No |
| Superiority or Other |
| Group comparisons of MMP-1 at Week 24 visit were made using fold change data. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.41 | No | Superiority or Other |
| Group comparisons of MMP-3 at Week 24 visit were made using fold change data. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.02 | No | Superiority or Other |
| Group comparisons of MMP-9 at Week 24 visit were made using fold change data. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.61 | No | Superiority or Other |
| Mild Erythema |
|
| Moderate Erythema |
|
| Marked Erythema |
|
| Deep Erythema |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values |
| 0.44 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.41 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.94 | No | Superiority or Other |
| Moderate |
|
| Severe |
|
| Moderate Flaking/Scaling |
|
| Marked Scaling/Fissuring |
|
| Severe Scaling/Fissuring |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Neutral |
|
| Dislike product |
|
| Strongly dislike product |
|
| Mild |
|
| Moderate |
|
| Severe |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values |
| 1.00 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.96 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.91 | No | Superiority or Other |
| Mild |
|
| Moderate |
|
| Severe |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values |
| 0.29 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.15 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.29 | No | Superiority or Other |
| Slight Flaking |
|
| Moderate Flaking/Scaling |
|
| Marked Scaling/Fissuring |
|
| Severe Scaling/Fissuring |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values |
| 0.06 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.02 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values | 0.09 | No | Superiority or Other |
| No |
|
| Fisher Exact |
| 0.70 |
| No |
| Superiority or Other |
| Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other. | Fisher Exact | 0.70 | No | Superiority or Other |
| Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other. | Fisher Exact | 0.35 | No | Superiority or Other |
| Mild |
|
| Moderate |
|
| Severe |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.31 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.25 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.46 | No | Superiority or Other |
| Mild |
|
| Moderate |
|
| Severe |
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.05 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.16 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.14 | No | Superiority or Other |
| Like product |
|
| Neutral |
|
| Dislike product |
|
| Strongly dislike product |
|
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.88 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.18 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.17 | No | Superiority or Other |
| A little stinging |
|
| A lot of stinging |
|
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| <0.01 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.04 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.10 | No | Superiority or Other |
| A little itching |
|
| A lot of itching |
|
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.02 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.08 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.15 | No | Superiority or Other |
| A little burning |
|
| A lot of burning |
|
|
Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application. |
| Wilcoxon (Mann-Whitney) |
Wilcoxon rank sum test with exact p-values. |
| 0.18 |
| No |
| Superiority or Other |
| Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.02 | No | Superiority or Other |
| Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application. | Wilcoxon (Mann-Whitney) | Wilcoxon rank sum test with exact p-values. | 0.42 | No | Superiority or Other |