A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
研究概览
简要总结
The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
- •Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
- •Presence of two (2) comparable target lesions
- •Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
- •Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.
排除标准
- •Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
- •Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
- •Significant confounding conditions as assessed by study doctor
- •History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
- •Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- •Pregnancy or lactation
研究组 & 干预措施
AN2898 ointment, 1%, vs. ointment vehicle
AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2898 ointment, 1% (Drug)
AN2898 ointment, 1%, vs. ointment vehicle
AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2898 ointment vehicle (Drug)
AN2728 ointment, 2%, vs. ointment vehicle
AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2728 ointment, 2% (Drug)
AN2728 ointment, 2%, vs. ointment vehicle
AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2728 ointment vehicle (Drug)
结局指标
主要结局
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
时间窗: Baseline (Day 1)
ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Atopic Dermatitis Severity Index (ADSI) Score at Day 28
时间窗: Day 28
ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Atopic Dermatitis Severity Index (ADSI) Score at Day 42
时间窗: Day 42
ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Atopic Dermatitis Severity Index (ADSI) Score at Day 14
时间窗: Day 14
ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
时间窗: Baseline (Day 1), Day 28
ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.
次要结局
未报告次要终点