Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group 1 ASC40 25mg for 12 weeks |
Drug: ASC40 25mg
25mg of ASC40 orally once daily for 12 weeks.
|
| Experimental: Experimental group 2 ASC40 50mg for 12 weeks |
Drug: ASC40 50mg
50mg of ASC40 orally once daily for 12 weeks.
|
| Experimental: Experimental group 3 ASC40 75mg for 12 weeks |
Drug: ASC40 75mg
75mg of ASC40 orally once daily for 12 weeks.
|
| Placebo Comparator: Placebo group Placebo for 12 weeks |
Drug: Placebo
Placebo orally once daily for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- Percentage change of total lesion count compared with baseline and week 12. [Baseline to week 12]
- Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12. [Baseline to week 12]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huashan Hospital Fudan University | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASC40-202