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

NCT06403501 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2025-07-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06403501 on ClinicalTrials.gov