Trials / Recruiting
RecruitingNCT06403501
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 692 (estimated)
- Sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-05-20
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2024-05-08
- Last updated
- 2025-07-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06403501. Inclusion in this directory is not an endorsement.