A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 213
- 试验地点
- 20
- 主要终点
- Absolute Change in Inflammatory Lesion Counts
研究概览
简要总结
This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
详细描述
A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe acne
- •25-70 non-inflammatory lesions at Baseline
- •20-40 inflammatory lesions at Baseline
排除标准
- •Subjects with known allergy to any component of the test material or vehicle
- •Women who are pregnant or nursing
研究组 & 干预措施
SB204 2% Twice daily
Twice daily SB204 2%
干预措施: SB204 2% (Drug)
SB204 4% daily
Once daily SB204 4%
干预措施: SB204 4% (Drug)
Vehicle Gel Daily
Vehicle Gel Daily
干预措施: Vehicle Gel (Drug)
Vehicle Gel Twice Daily
Twice daily Vehicle Gel
干预措施: Vehicle Gel (Drug)
SB204 4% Twice Daily
Twice daily SB204 4%
干预措施: SB204 4% (Drug)
结局指标
主要结局
Absolute Change in Inflammatory Lesion Counts
时间窗: Baseline and Week 12
Change in inflammatory lesion count from Baseline to Week 12
Absolute Change in Non-inflammatory Lesion Counts
时间窗: Baseline and Week 12
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
时间窗: Baseline and Week 12
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)
次要结局
- Percent Change in Inflammatory Lesion Count From Baseline to Week 12(Baseline and Week 12)
- Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12(Baseline and Week 12)
- Median Time to Improvement(Baseline through Week 12)