Actively Recruiting
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Led by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Updated on 2025-07-09
692
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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