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

Ascletis

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: ASC40 25mg; Drug: ASC40 75mg; Drug: Placebo; Drug: ASC40 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05104125

ASC40-202

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

Experimental group 1

Experimental group

Description:

ASC40 25mg for 12 weeks

Treatment:

Drug: ASC40 25mg

Experimental group 2

Experimental group

Description:

ASC40 50mg for 12 weeks

Treatment:

Drug: ASC40 50mg

Experimental group 3

Experimental group

Description:

ASC40 75mg for 12 weeks

Treatment:

Drug: ASC40 75mg

Placebo group

Placebo Comparator group

Description:

Placebo for 12 weeks

Treatment:

Drug: Placebo