drugset / Trial / NCT07457294

1% Clascoterone Cream for the Treatment Acne Vulgaris

NCT07457294

Phase 3 Not yet recruiting 692 enrolled Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of acne vulgaris. Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria. Treatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.

Timeline

Start
2026-05-04
Primary completion
2028-08-07
Completion
2029-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Clascoterone Small molecule 1 % Topical

Indications