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

NCT ID: NCT06403501

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 692 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Clascoterone Cream 1%

Clascoterone Cream 1% (Winlevi)

Group Type: EXPERIMENTAL

Clascoterone

Intervention Type: DRUG

Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Vehicle cream

Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Group Type: PLACEBO_COMPARATOR

Vehicle cream

Intervention Type: DRUG

Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Interventions

Clascoterone

Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Intervention Type: DRUG

Vehicle cream

Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Intervention Type: DRUG

Other Intervention Names

Winlevi (brand name)

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shuyang Zhao

Role: primary

zhaoshuyang@wsh.3sbio.com

13123927303

Other Identifiers

LWY23090C

Identifier Type: -

Identifier Source: org_study_id