Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
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
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
692 participants
May 20, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria13
- 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.
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Interventions
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06403501