A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 10
- 主要终点
- Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
详细描述
Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 12 years of age.
- •Facial acne, with:
- •20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face
排除标准
- •Women who are pregnant or breastfeeding
- •Skin diseases other than acne vulgaris
- •Use of oral retinoids within 6 months of Baseline Visit
- •Unwilling to discontinue all other treatments for facial acne
- •Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
研究组 & 干预措施
1
Vehicle control cream applied topically to the face twice daily for 12 weeks
干预措施: placebo (Drug)
2
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
干预措施: ASC-J9 cream (Drug)
3
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
干预措施: ASC-J9 cream (Drug)
4
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
干预措施: ASC-J9 cream (Drug)
结局指标
主要结局
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
时间窗: Baseline to Week 12
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
次要结局
- Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12(Baseline to Week 12)