NCT06415292

A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients

A Clinical Study to Assess the Barrier Impact of Winlevi

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Winlevi (clascoterone) 1% cream	Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.

Timeline

• Start date: 2023-11-27
• Primary completion: 2023-12-16
• Completion: 2023-12-16
• First posted: 2024-05-16
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study