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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-12

Study Completion Date

2023-04-10

Brief Summary

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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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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group 1

ASC40 25mg for 12 weeks

Group Type EXPERIMENTAL

ASC40 25mg

Intervention Type DRUG

25mg of ASC40 orally once daily for 12 weeks.

Experimental group 2

ASC40 50mg for 12 weeks

Group Type EXPERIMENTAL

ASC40 50mg

Intervention Type DRUG

50mg of ASC40 orally once daily for 12 weeks.

Experimental group 3

ASC40 75mg for 12 weeks

Group Type EXPERIMENTAL

ASC40 75mg

Intervention Type DRUG

75mg of ASC40 orally once daily for 12 weeks.

Placebo group

Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo orally once daily for 12 weeks.

Interventions

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ASC40 25mg

25mg of ASC40 orally once daily for 12 weeks.

Intervention Type DRUG

ASC40 50mg

50mg of ASC40 orally once daily for 12 weeks.

Intervention Type DRUG

ASC40 75mg

75mg of ASC40 orally once daily for 12 weeks.

Intervention Type DRUG

Placebo

Placebo orally once daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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);

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No