Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris (NCT06403501) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
China692 participantsStarted 2024-05-20
Plain-language 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.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Timeframe: Week 12
2
Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Timeframe: Week 12
3
Change From Baseline in Inflammatory Lesion (IL) Counts