A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients - Trial NCT06415279
Access comprehensive clinical trial information for NCT06415279 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 40 participants.
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Study Focus
Sponsor & Location
Sun Pharmaceutical Industries Limited
Timeline & Enrollment
Phase 4
Feb 29, 2024
Apr 01, 2025
Primary Outcome
The primary efficacy endpoint is the reduction in causal sebum measurements from the forehead obtained with a sebumeter during the 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06415279
Non-Device Trial