Acne Vulgaris
Conditions
Keywords
Acne Vulgaris
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.
Interventions
DRUGClascoterone
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
DRUGVehicle cream
Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.
Sponsors
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) | 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 | Week 12 | Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12. |
| Change From Baseline in Inflammatory Lesion (IL) Counts | Week 12 | Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Lesion Counts | Week 12 | Absolute change from Baseline in total lesions counts in each treatment group at Week 12. |
| Percent Change From Baseline in Non-inflammatory Lesion Counts | Week 12 | Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12. |
| Percent Change From Baseline in Total Lesion Counts | Week 12 | Percent change from Baseline in total lesions counts in each treatment group at Week 12. |
| Percent Change From Baseline in Inflammatory Lesion Counts | Week 12 | Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12. |
Countries
China
Outcome results
None listed