NCT07457294

1% Clascoterone Cream for the Treatment Acne Vulgaris

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of 1% Clascoterone Cream in the Treatment of Acne Vulgaris

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (estimated)
• Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	1% Clascoterone Cream	1% Clascoterone Cream applied topically to affected areas twice daily for the duration of the study.
DRUG	Placebo	Placebo cream, matching the 1% Clascoterone Cream in appearance, texture, and scent, applied topically to affected areas twice daily for the duration of the study.

Timeline

• Start date: 2026-05-04
• Primary completion: 2028-08-07
• Completion: 2029-02-07
• First posted: 2026-03-09
• Last updated: 2026-03-09