Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

Phase 3

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: Vehicle cream; Drug: Clascoterone

• Registration Number: NCT06403501
• Lead Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Brief Summary

The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-05
• Study First Posted: 2024-05-08
• Study Start: 2024-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 692

Inclusion Criteria

• Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);
• Male or female, 12 years of age or older;
• Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.

Exclusion Criteria

• Subject has greater than two (2) facial nodules;
• Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;
• Subject has used topical and systemic anti-acne medications or therapies;
• Subject has received hormonal therapy for acne treatment;
• Subject has used a skincare product with acne removal effect;
• Subject has other serious underlying diseases such as mental illness or malignant tumors;
• Subject has any of the clinically significant laboratory test indicators at screening;
• Subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles;
• Subject engaged in drug abuse or excessive alcohol intake;
• Subject has uncontrolled hypertension; Subject has poorly controlled diabetes;
• Subject is pregnant, lactating, or is planning to become pregnant during the study (both male and female); subject has positive pregnancy test result; subject is unable to practice highly effective contraception methods during the trial and within 3 months after the end of the trial;
• Subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment;
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle cream	Vehicle cream	Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.
Clascoterone Cream 1%	Clascoterone	Clascoterone Cream 1% (Winlevi)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Inflammatory Lesion (IL) Counts	Week 12	Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)	Week 12	Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Change From Baseline in Non-inflammatory Lesion (NIL) Counts	Week 12	Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Lesion Counts	Week 12	Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Change From Baseline in Total Lesion Counts	Week 12	Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Percent Change From Baseline in Inflammatory Lesion Counts	Week 12	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Percent Change From Baseline in Non-inflammatory Lesion Counts	Week 12	Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.

Trial Locations

Locations (1)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, China