Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 165
- 主要终点
- Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
研究概览
简要总结
Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% 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: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
- •Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.
排除标准
- •Non-compliance with washout period
- •Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
- •Allergy or sensitivity to any component of the test medications
- •Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
研究组 & 干预措施
Tazarotene Cream 0.1%
1 pea-size amount, QD x 16 weeks
干预措施: Tazarotene Cream 0.1% (Drug)
Adapalene Gel 0.3%
1 pea-size amount, QD x 16 weeks
干预措施: Adapalene (Drug)
结局指标
主要结局
Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
时间窗: Baseline, Week 12
Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).
次要结局
- Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16(Week 16)
- Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12(Week 12)
- Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16(Baseline, Week 16)