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

Inclusion Criteria:

• Diagnosed with facial acne vulgaris (which includes the nose) from moderate tosevere, 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 30to 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 signthe written informed consent. A subject under 18 years of age must provide writteninformed assent and be accompanied by the parent or legal guardian at the time ofconsent signing.

Exclusion Criteria:

• Subject has greater than two (2) facial nodules;

• Subject has any skin pathology or condition that could interfere with theinvestigator'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 malignanttumors;

• Subject has any of the clinically significant laboratory test indicators atscreening;

• 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 isunable to practice highly effective contraception methods during the trial andwithin 3 months after the end of the trial;

• Subject is currently enrolled or was enrolled in other clinical trials within 3months prior to the initiation of treatment;

• Subject has any condition which, in the investigator's opinion, would make it unsafefor the subject to participate in this clinical trial.