Pure Global
NCT06415305

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

The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne
Sun Pharmaceutical Industries Limited·Phase 4·ClinicalTrials.gov·drugRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Acne Vulgaris
Drug/Device/Intervention
Winlevi (clascoterone) 1% cream
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sun Pharmaceutical Industries Limited
Location
Louisville, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Sep 01, 2023
End date
Dec 01, 2024
Enrollment
10 participants
Primary outcome

The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16.

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 a 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.

ICD-10 classifications
Acne vulgarisAcneAcne, unspecifiedAcné excoriéeOther acne
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06415305
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06415305 through Pure Global AI's free database. This Phase 4 trial is sponsored by Sun Pharmaceutical Industries Limited and is currently Recruitment Completed. The study focuses on Acne Vulgaris. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.