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Completed

NCT Number: NCT05104125

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASC40 25mg

Drug

25mg of ASC40 orally once daily for 12 weeks.

ASC40 50mg

Drug

50mg of ASC40 orally once daily for 12 weeks.

ASC40 75mg

Drug

75mg of ASC40 orally once daily for 12 weeks.

Placebo

Drug

Placebo orally once daily for 12 weeks.

Primary outcomes

  1. Percentage change of total lesion count compared with baseline and week 12.

    Time frame: Baseline to week 12

  2. Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.

    Time frame: Baseline to week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline to week 2, 4, 8 and 12

  2. 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

    Time frame: Baseline to week 2, 4, 8 and 12

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2021
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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