Testing clascoterone cream for treating facial acne

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Huashan Hospital, Fudan University
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Denifanstat vs placebo for moderate to severe acne in teens and adults

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• Facial skin microbiome changes during isotretinoin in moderate-to-severe acne

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• Hormonal profiles and isotretinoin response in adult women with acne

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.