A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with 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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 12 to 17 years of age, inclusive
- •Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
- •Total body surface area (BSA) of atopic dermatitis involvement ≤35%
- •Presence of two comparable target lesions
- •Willing and able to comply with study instructions and commit to attending all visits
- •Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
- •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
排除标准
- •Significant confounding conditions as assessed by study doctor
- •Unstable or actively infected AD
- •Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
- •History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
- •Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
- •Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
- •Current pregnancy or lactation, or intent to become pregnant during the study
- •Known sensitivity to any of the components of the study drug
- •Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- •Participated in a previous AN2728 clinical study
研究组 & 干预措施
AN2728 Topical Ointment, 2% QD vs 0.5% QD
AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2728 Topical Ointment, 2% QD (Drug)
AN2728 Topical Ointment, 2% QD vs 0.5% QD
AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2728 Topical Ointment, 0.5% QD (Drug)
AN2728 Topical Ointment, 2% BID vs 0.5% BID
AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion.
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2728 Topical Ointment, 2% BID (Drug)
AN2728 Topical Ointment, 2% BID vs 0.5% BID
AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion.
Treatments will be randomly assigned to target lesions A and B.
干预措施: AN2728 Topical Ointment, 0.5% BID (Drug)
结局指标
主要结局
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
时间窗: Baseline, Day 8
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
时间窗: Baseline, Day 29
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
时间窗: Baseline, Day 15
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
时间窗: Baseline, Day 22
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
次要结局
- Number of Participants With Local Tolerability Symptoms(Baseline up to Day 29)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Day 29)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline up to Day 29)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities(Baseline up to Day 29)
- Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29(Baseline, Day 8, 15, 22, 29)
- Number of Participants With Treatment-Emergent Adverse Events By Severity(Baseline up to Day 29)