CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled / 40 target
Drug / intervention
Winlevi (clascoterone) 1% creamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06415279
NCT06415279Phase 4CompletedOn Track (1.4/mo)Completion was 16mo ago
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Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1%

Sun Pharmaceutical Industries Limited·interventional·Posted May 16, 2024·Updated Jun 15, 2026

In Brief

A Phase 4 clinical trial evaluating Winlevi (clascoterone) 1% cream for Acne Vulgaris. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20252026
First PostedMay 16, 2024
Enrollment StartFeb 14, 2024
Primary CompletionFeb 12, 2025
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 2.1 years ago

Arms & Interventions

Winlevi (clascoterone) 1% creamexperimental

Drug: Winlevi (clascoterone) 1% cream

Interventions

Winlevi (clascoterone) 1% creamdrug

Twice daily (BID) dosing