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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 692
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Inflammatory Lesion (IL) Counts
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Clascoterone Cream 1%
Clascoterone Cream 1% (Winlevi)
Intervention: Clascoterone (Drug)
Vehicle cream
Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.
Intervention: Vehicle cream (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Inflammatory Lesion (IL) Counts
Time Frame: 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)
Time Frame: 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
Time Frame: Week 12
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Secondary Outcomes
- Percent Change From Baseline in Total Lesion Counts(Week 12)
- Change From Baseline in Total Lesion Counts(Week 12)
- Percent Change From Baseline in Inflammatory Lesion Counts(Week 12)
- Percent Change From Baseline in Non-inflammatory Lesion Counts(Week 12)