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.

  • STATUS
    Recruiting
  • participants needed
    180
  • sponsor
    Ascletis Pharmaceuticals Co., Ltd.
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Updated on 10 October 2022
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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.

Description


Details
Condition ADHD
Age 18years - 40years
Treatment Placebo, ASC40 25mg, ASC40 50mg, ASC40 75mg
Clinical Study IdentifierNCT05104125
SponsorAscletis Pharmaceuticals Co., Ltd.
Last Modified on10 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

-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)

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
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