Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris

The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Vehicle cream; Drug: Clascoterone

• Study Type: Interventional
• Enrollment (Estimated): 692
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Huashan Hospital, Fudan University
    • Contact: Shuyang Zhao; Phone Number: 13123927303; Email: zhaoshuyang@wsh.3sbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);
• Male or female, 12 years of age or older;
• Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.

Exclusion Criteria:

• Subject has greater than two (2) facial nodules;
• Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;
• Subject has used topical and systemic anti-acne medications or therapies;
• Subject has received hormonal therapy for acne treatment;
• Subject has used a skincare product with acne removal effect;
• Subject has other serious underlying diseases such as mental illness or malignant tumors;
• Subject has any of the clinically significant laboratory test indicators at screening;
• Subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles;
• Subject engaged in drug abuse or excessive alcohol intake;
• Subject has uncontrolled hypertension; Subject has poorly controlled diabetes;
• Subject is pregnant, lactating, or is planning to become pregnant during the study (both male and female); subject has positive pregnancy test result; subject is unable to practice highly effective contraception methods during the trial and within 3 months after the end of the trial;
• Subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment;
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clascoterone Cream 1%; Clascoterone Cream 1% (Winlevi)	Drug: Clascoterone; Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.; Other Names: Winlevi (brand name)
Placebo Comparator: Vehicle cream; Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.	Drug: Vehicle cream; Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)	Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.	Week 12
Change From Baseline in Non-inflammatory Lesion (NIL) Counts	Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.	Week 12
Change From Baseline in Inflammatory Lesion (IL) Counts	Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Lesion Counts	Absolute change from Baseline in total lesions counts in each treatment group at Week 12.	Week 12
Percent Change From Baseline in Total Lesion Counts	Percent change from Baseline in total lesions counts in each treatment group at Week 12.	Week 12
Percent Change From Baseline in Inflammatory Lesion Counts	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.	Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts	Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.	Week 12

Collaborators and Investigators

• Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Acne Vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: LWY23090C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No