Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 163
- 主要终点
- Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
研究概览
简要总结
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Facial acne vulgaris characterized by the following:
- •30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
- •Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
- •Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
排除标准
- •Non-compliance with washout period;
- •History of clinically significant anemia or hemolysis;
- •Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
- •Allergy or sensitivity to any component of the test medications
研究组 & 干预措施
1
Dapsone gel 5% and Tretinoin gel 0.025%
干预措施: Dapsone; Tretinoin (Drug)
2
Tretinoin gel 0.025%
干预措施: Tretinoin (Drug)
结局指标
主要结局
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
时间窗: Baseline, Week 12
Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
次要结局
- Change From Baseline in Investigator Global Assessment at Week 12(Baseline, Week 12)
- Change From Baseline in Overall Disease Severity at Week 12(Baseline, Week 12)
- Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12(Baseline, Week 12)