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NOT YET RECRUITING
NCT07457294
PHASE3

1% Clascoterone Cream for the Treatment Acne Vulgaris

Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

692

Start Date

2026-05-04

Completion Date

2029-02-07

Last Updated

2026-03-09

Healthy Volunteers

No

Conditions

Interventions

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.