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

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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05104125

Enrollment

180

Registered

2021-11-02

Start date

2022-01-12

Completion date

2023-04-10

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne vulgaris, ASC40

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.

Interventions

DRUGASC40 25mg

25mg of ASC40 orally once daily for 12 weeks.

DRUGASC40 50mg

50mg of ASC40 orally once daily for 12 weeks.

DRUGASC40 75mg

75mg of ASC40 orally once daily for 12 weeks.

DRUGPlacebo

Placebo orally once daily for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026