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A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne

NCT06415305 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-16

Study results available
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Summary

Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation.

Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Winlevi (clascoterone) 1% cream

Dosed twice daily (BID)

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-04-17
Completion
2025-01-30
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 NCT06415305 on ClinicalTrials.gov