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RECRUITING
NCT06403501
PHASE3

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

Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

692

Start Date

2024-05-20

Completion Date

2026-10

Last Updated

2025-07-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Clascoterone

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

DRUG

Vehicle cream

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

Locations (1)

Huashan Hospital, Fudan University

Shanghai, China