NCT01209949已完成4 期
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
研究概览
简要总结
The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged 16 to 25 years inclusive;
- •Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
- •A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
- •Subjects who agree to be photographed at each visit;
- •Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study
排除标准
- •Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
- •Subjects with a wash-out period for topical acne treatment on the face less than 30 days
- •Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
- •Subjects who are currently being treated with antibiotics;
- •Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
- •Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
研究组 & 干预措施
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Other
干预措施: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel (Drug)
结局指标
主要结局
Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
时间窗: 12 weeks
Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
次要结局
- Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.(Week 12)
- Number of Participants With Tolerability Assessments Resulting in an Adverse Event(12 weeks)
研究者
研究点 (1)
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