NCT05104125已完成2 期
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-dose Study to Evaluate Safety and Efficacy of ASC40 Tablets in Subjects With Moderate to Severe 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
- 180
- 试验地点
- 1
- 主要终点
- Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
研究概览
简要总结
This is a phase2, randomized, double-blind, multi-center, multi-dose and placebo parallel controlled design. The subjects in the study group were given double-blind drugs, and they were taken (orally) after dinner every day according to the requirements of clinical trial scheme.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-40 years old (including 18 and 40 years old);
- •Investigator's Global Assessment of subject at baseline period was at 3-
- •Facial skin lesions of subject need counting as follows: 30 ~ 75 inflammatory lesions (the total number of papules, pustules and nodules is 30 ~ 75, including no more than 2 nodules), 30 ~ 100 non-inflammatory lesions (the total number of open and closed comedones is 30 ~ 100);
排除标准
- •Known to be allergic or hypersensitive to ASC40 tablets;
- •Facial nodules of subject is more than 2 facial nodules
- •The subject with cystic acne
- •Subject with secondary acne such as occupational acne (e.g., chloroacne) and acne caused by corticosteroids (e.g., chloroacne or acne caused by drugs);
- •Serum AST, ALT≥3ULN and Cr exceeded the upper limit of normal range
研究组 & 干预措施
Experimental group 1
Experimental
ASC40 25mg for 12 weeks
干预措施: ASC40 25mg (Drug)
Experimental group 2
Experimental
ASC40 50mg for 12 weeks
干预措施: ASC40 50mg (Drug)
Experimental group 3
Experimental
ASC40 75mg for 12 weeks
干预措施: ASC40 75mg (Drug)
Placebo group
Placebo Comparator
Placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
时间窗: Baseline to week 12
Percentage change of total lesion count compared with baseline and week 12.
时间窗: Baseline to week 12
次要结局
- The changes status and changes of average percentage of inflammatory skin lesions count, non-inflammatory skin lesions count and total skin lesions count compared with baseline.(Baseline to week 2, 4, 8 and 12)
- Ratio of subjects, whose GA grades was 1 or 0, or GA grades was decreased y ≥2 grades compared with baseline and Improvements in classification(Baseline to week 2, 4, 8 and 12)
研究者
研究点 (1)
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