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A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients

NCT06415279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-15

No results posted yet for this study

Summary

The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. A newly FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production. This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval. This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Winlevi (clascoterone) 1% cream

Twice daily (BID) dosing

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
2024-02-29
Primary Completion
2025-02-18
Completion
2025-02-18
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 NCT06415279 on ClinicalTrials.gov