A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Local Tolerability - Skin Dryness
研究概览
简要总结
The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
- •Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
排除标准
- •Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.
研究组 & 干预措施
CTGel plus BPO wash
Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening
干预措施: CTGel/ BPO Wash (Drug)
CTGel
Soap Free Cleanser in the morning and CTGel in the evening
干预措施: Soap Free Cleanser and CTGel (Drug)
结局指标
主要结局
Local Tolerability - Skin Dryness
时间窗: Week 4
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Scaling
时间窗: Week 4
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Erythema (Redness)
时间窗: Week 4
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
次要结局
- Subject Assessment of Burning/Stinging(Week 4)
- Subject Assessment of Itching(Week 4)