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| ID | Type | Description | Link |
|---|---|---|---|
| A3191007 | Other Identifier | Pfizer |
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The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN2728 Topical Ointment, 2% | Experimental | AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2728 Topical Ointment, 2% | Drug | AN2728 Topical Ointment, 2% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local Tolerability Symptoms According to Severity on Baseline | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure. | Baseline |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 2 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure. | Day 2 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 4 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure. | Day 4 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 6 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) | ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29. |
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Inclusion Criteria:
Male or female 12 to 17 years of age, inclusive
Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
AD in treatable areas (excludes the scalp and venous access areas) involving
≥10% and ≤35% of the total body surface area(BSA)
Investigator's Static Global Assessment (ISGA) score of 2 or 3
Normal or not clinically significant screening laboratory results
Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site
Willing and able to comply with study instructions and commit to attending all visits
Females must use a highly effective method of birth control.
Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anacor Investigational Site | Fremont | California | 94538 | United States | ||
| Anacor Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AN2728 Topical Ointment 2 Percent | AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate atopic dermatitis (AD), twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who were enrolled and had received any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | AN2728 Topical Ointment 2 Percent | AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator. |
| 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 | Number of Participants With Local Tolerability Symptoms According to Severity on Baseline | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Baseline |
|
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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 | AN2728 Topical Ointment 2 Percent | AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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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| Day 6 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 8 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure. | Day 8 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 9 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure. | Day 9 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 15 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure. | Day 15 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 22 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure. | Day 22 |
| Number of Participants With Local Tolerability Symptoms According to Severity on Day 29 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure. | Day 29 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state. | Baseline (Day 1) up to Day 29 |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline (Day 1) up to Day 29 |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion. | Baseline (Day 1) up to Day 29 |
| Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 |
| Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. | Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1 |
| Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 |
| Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 |
| Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. | Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8 |
| Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 |
| Baseline up to Day 29 |
| Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29 | 5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis. | Baseline, Day 8, 15, 22, 29 |
| San Diego |
| California |
| 92123 |
| United States |
| Anacor Investigational Site | Indianapolis | Indiana | 46256 | United States |
| Anacor Investigational Site | High Point | North Carolina | 27262 | United States |
| Anacor Investigational Site | Winston-Salem | North Carolina | 27104 | United States |
| Anacor Investigational Site | Houston | Texas | 77030 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 2 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 2 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 4 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 4 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 6 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 6 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 8 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 8 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 9 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 9 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 15 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 15 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 22 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 22 |
|
|
|
| Primary | Number of Participants With Local Tolerability Symptoms According to Severity on Day 29 | Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Day 29 |
|
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
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| Primary | Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
|
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| Primary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Number | participants | Baseline (Day 1) up to Day 29 |
|
|
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| Primary | Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. | Pharmacokinetic (PK) population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. | Posted | Mean | Standard Deviation | nanogram per milliliter | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 |
|
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| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. | Posted | Median | Full Range | hour | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 |
|
|
|
| Primary | Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter | Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1 |
|
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| Primary | Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 | Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, "n" signifies number of participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | hour | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, "Number of Participants Analyzed" (N) signifies evaluable participants for this outcome measure. | Posted | Mean | Standard Deviation | nanogram per milliliter | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 |
|
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| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure. | Posted | Median | Full Range | hour | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 |
|
|
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| Primary | Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter | Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8 |
|
|
|
| Primary | Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 | Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma. | PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, "n" signifies number of participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | hour | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 |
|
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| Secondary | Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) | ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
|
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| Secondary | Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29 | 5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis. | Safety population included all participants who were enrolled and had received any amount of the study drug. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 8, 15, 22, 29 |
|
|
|
| 0 |
| 23 |
| 10 |
| 23 |
| Application site discomfort | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment | This event was gender specific. |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Milia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Change at Day 22: Erythema |
|
| Change at Day 29: Erythema |
|
| Baseline: Pruritus |
|
| Change at Day 8: Pruritus |
|
| Change at Day 15: Pruritus |
|
| Change at Day 22: Pruritus |
|
| Change at Day 29: Pruritus |
|
| Baseline: Exudation |
|
| Change at Day 8: Exudation |
|
| Change at Day 15: Exudation |
|
| Change at Day 22: Exudation |
|
| Change at Day 29: Exudation |
|
| Baseline: Excoriation |
|
| Change at Day 8: Excoriation |
|
| Change at Day 15: Excoriation |
|
| Change at Day 22: Excoriation |
|
| Change at Day 29: Excoriation |
|
| Baseline: Lichenification |
|
| Change at Day 8: Lichenification |
|
| Change at Day 15: Lichenification |
|
| Change at Day 22: Lichenification |
|
| Change at Day 29: Lichenification |
|