NCT01289574已完成2 期
Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 7
- 主要终点
- Percent Change in Inflammatory Acne Lesion Counts
研究概览
简要总结
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.
详细描述
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.
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 at the time of enrollment
- •Facial acne, with:
- •20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
- •20-100 noninflammatory facial lesions (open and closed comedones);
- •No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
- •Investigator's Global Assessment (IGA) acne score of 3 or
排除标准
- •Females who are pregnant or breast-feeding
- •Skin diseases other than acne vulgaris
- •Use of other topical or systemic treatments for acne
- •Other significant medical conditions or clinically significant abnormal laboratory test results.
研究组 & 干预措施
Vehicle control cream
Placebo Comparator
干预措施: ASC-J9 (Drug)
0.025% ASC-J9 cream
Experimental
干预措施: ASC-J9 (Drug)
0.1% ASC-J9 cream
Experimental
干预措施: ASC-J9 (Drug)
结局指标
主要结局
Percent Change in Inflammatory Acne Lesion Counts
时间窗: 12 weeks
Percent change from Baseline
次要结局
- Success on Investigator Global Assessment (IGA) at Week 12(12 weeks)
- Percent Change in Noninflammatory Acne Lesion Counts(12 weeks)
研究者
研究点 (7)
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