A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Evaluation of Twice Daily PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis in Subjects 3 Months to Less Than 18 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 9
- 主要终点
- "Treatment Success" based on change in Investigator's Global Assessment (IGA)
研究概览
简要总结
This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis.
- •Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study.
排除标准
- •Subject is pregnant, lactating or is planning to become pregnant during the study.
- •Subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period.
- •Subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start.
- •Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start.
- •Subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin D preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, within 14 days prior to study start.
- •Subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study.
- •Subject has used systemic (oral, IV, etc.) antibiotic therapy within seven days prior to study start.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.
研究组 & 干预措施
PDI-192 Foam, 0.15%
topical foam, 0.15% concentration, twice daily
干预措施: PDI-192 (Drug)
Vehicle Foam
topical foam, 0% concentration, twice daily
干预措施: Vehicle (Drug)
PDI-192 Foam, 0.1%
topical foam, 0.1% concentration, twice daily
干预措施: PDI-192 (Drug)
结局指标
主要结局
"Treatment Success" based on change in Investigator's Global Assessment (IGA)
时间窗: Baseline and Day 29
Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.
次要结局
- Change in Pruritis Severity at Day 29(Baseline and Day 29)