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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403501
• Other study ID #: LWY23090C
• Status: Recruiting
• Phase: Phase 3
• Start date: May 20, 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 692
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Clascoterone
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
• Vehicle cream
Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)	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.	Week 12
Primary	Change From Baseline in Non-inflammatory Lesion (NIL) Counts	Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.	Week 12
Primary	Change From Baseline in Inflammatory Lesion (IL) Counts	Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.	Week 12
Secondary	Change From Baseline in Total Lesion Counts	Absolute change from Baseline in total lesions counts in each treatment group at Week 12.	Week 12
Secondary	Percent Change From Baseline in Total Lesion Counts	Percent change from Baseline in total lesions counts in each treatment group at Week 12.	Week 12
Secondary	Percent Change From Baseline in Inflammatory Lesion Counts	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.	Week 12
Secondary	Percent Change From Baseline in Non-inflammatory Lesion Counts	Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.	Week 12