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1% Clascoterone Cream for the Treatment Acne Vulgaris

NCT07457294 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2026-03-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457294 on ClinicalTrials.gov