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

May 24, 2023 updated by: Ascletis Pharmaceuticals Co., Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Huashan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change of total lesion count compared with baseline and week 12.
Time Frame: Baseline to week 12
Baseline to week 12
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Time Frame: Baseline to week 12
Baseline to week 12

Secondary Outcome Measures

Outcome 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.
Time Frame: Baseline to week 2, 4, 8 and 12
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
Time Frame: Baseline to week 2, 4, 8 and 12
Baseline to week 2, 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC40-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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