Testing clascoterone cream for treating facial acne

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

This study is testing if a new clascoterone cream can help people aged 12 and older with moderate to severe facial acne improve their skin over 12 weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06403501 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of clascoterone cream at a concentration of 1% compared to a vehicle cream in patients with moderate to severe facial acne vulgaris. Participants will apply the cream twice daily for a duration of 12 weeks. The study aims to assess the reduction in inflammatory and non-inflammatory lesions as well as overall skin condition improvement. The trial includes both male and female subjects aged 12 and older who meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 years and older diagnosed with moderate to severe facial acne vulgaris.

Not a fit: Patients with more than two facial nodules or those currently using other anti-acne therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective topical option for patients suffering from moderate to severe acne vulgaris.

How similar studies have performed: Previous studies have shown promise with similar topical treatments for acne, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Huashan Hospital, Fudan University — Shanghai, China (Recruiting)

Conditions Acne Vulgaris