NCT06415279

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Winlevi (clascoterone) 1% cream	Twice daily (BID) dosing

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2024-05-16
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study