Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

• Clascoterone (Drug), also known as Winlevi (brand name): Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
• Vehicle cream (Drug): Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Primary outcomes

• 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 outcomes

• 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 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.
• 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.

Sex: All, ages: 12 Years to any

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.