A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 1,330
- 试验地点
- 55
- 主要终点
- Absolute Change From Baseline in Non-inflammatory Lesion Counts
研究概览
简要总结
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
详细描述
This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
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
- 9 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe acne
- •Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
- •Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)
排除标准
- •Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
- •Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne
研究组 & 干预措施
SB204 4%
SB204 4% topically once daily
干预措施: SB204 4% (Drug)
Vehicle Gel
Vehicle Gel topically once daily
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Absolute Change From Baseline in Non-inflammatory Lesion Counts
时间窗: Baseline and Week 12
The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Absolute Change From Baseline in Inflammatory Lesion Counts
时间窗: Baseline and Week 12
The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
时间窗: Week 12
Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. 1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). 2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. 3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. 4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions
次要结局
- Percent Change in Inflammatory Lesion Count(Baseline and Week 12)
- Percent Change in Non-inflammatory Lesion Count(Baseline and Week 12)
- Time to Reduction in Inflammatory Lesion Count(Week 12)
- Time to Improvement in IGA(Week 12)