Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris

• Status: Not yet recruiting
• Trial end date: 2022-12-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

Criteria

Key Inclusion Criteria:

• 18-40 years old (including 18 and 40 years old);

• Investigator's Global Assessment of subject at baseline period was at 3-4.

• 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);

Key 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