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

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Status and phase

Enrolling

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Clascoterone

Drug: Vehicle cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT06403501

LWY23090C

Details and patient eligibility

About

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.

Enrollment

692 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.