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

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.

Timeline

Start

2024-02-14

Primary completion

2025-02-12

Completion

2025-02-12

Outcome

Met primary endpoint

registry MEAN Winlevi (Clascoterone) 1% Cream: -27.33 (Standard Deviation 50.79) µg/cm² NCT06415279 ↗

registry analysis (superiority test); Winlevi (Clascoterone) 1% Cream; p = 0.003; Wilcoxon signed rank test NCT06415279 ↗

Publications

• Draelos ZD, Kyeremateng K, Squittieri N. Reduction in Facial Sebum Production Following Treatment with Clascoterone Cream 1% in Patients with Acne Vulgaris: 12-Week Interim Analysis. Dermatol Ther (Heidelb). 2025 Sep;15(9):2657-2666. doi: 10.1007/s13555-025-01495-y. Epub 2025 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clascoterone	Unknown	1 %	—

Indications