Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
ConditionAcne Vulgaris
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Clascoterone
- Vehicle cream
Treatment groups
692 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov