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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: ASC40 75mg; Drug: ASC40 25mg; Drug: ASC40 50mg; Drug: Placebo

• Registration Number: NCT05104125
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-02
• Study Start: 2022-01-12
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 3	ASC40 75mg	ASC40 75mg for 12 weeks
Experimental group 1	ASC40 25mg	ASC40 25mg for 12 weeks
Experimental group 2	ASC40 50mg	ASC40 50mg for 12 weeks
Placebo group	Placebo	Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.	Baseline to week 12
Percentage change of total lesion count compared with baseline and week 12.	Baseline to week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Huashan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China