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COMPLETED
NCT06415279
PHASE4

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

Sponsor: Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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. An 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.

Official title: Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1%

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-02-14

Completion Date

2025-02-12

Last Updated

2026-06-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

Winlevi (clascoterone) 1% cream

Twice daily (BID) dosing

Locations (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States