NCT05104125
Completed
Phase 2
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.
ConditionsAcne Vulgaris
Overview
- Phase
- Phase 2
- Intervention
- ASC40 25mg
- Conditions
- Acne Vulgaris
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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);
Exclusion Criteria
- •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
Arms & Interventions
Experimental group 1
ASC40 25mg for 12 weeks
Intervention: ASC40 25mg
Experimental group 2
ASC40 50mg for 12 weeks
Intervention: ASC40 50mg
Experimental group 3
ASC40 75mg for 12 weeks
Intervention: ASC40 75mg
Placebo group
Placebo for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Time Frame: Baseline to week 12
Percentage change of total lesion count compared with baseline and week 12.
Time Frame: Baseline to week 12
Secondary Outcomes
- 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)
Study Sites (1)
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