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

NCT06415292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-04

Study results available
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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

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.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2023-12-16
Completion
2023-12-16
FDA Drug
Yes

Countries

  • United States

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 NCT06415292 on ClinicalTrials.gov