1% Clascoterone Cream for the Treatment Acne Vulgaris
ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
About this trial
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of acne vulgaris.
Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria.
Treatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.
Eligibility criteria
Qualifiers
Participants who are able to understand and comply with the protocol, voluntarily participate in the study, and sign the written informed consent form (ICF); for a participant aged <18 years, the written ICF must be co-signed by the minor participant and a parent or legal guardian based on informed consent;
Age ≥12 years at the time of ICF signing, regardless of gender;
Diagnosis of moderate to severe acne vulgaris (including the nose) at screening and randomization, with an IGA score of 3 or 4, and facial lesions meeting the following criteria: 30-75 inflammatory lesions (papules, pustules, and nodules) and 30-100 non-inflammatory lesions (open and closed comedones);
Participants have used the same brand and type of skin and hair care products for at least 2 weeks prior to randomization and agree to continue the current products and regimen during the study period;
Disqualifiers
Participants have more than 2 facial nodules at screening or randomization;
Participants have facial cysts at screening or randomization;
Participants have conditions at screening or randomization, which may interfere with the investigator's clinical assessments, including but not limited to: 1) Other facial dermatoses: specific types of acne (e.g., nodulocystic acne, acne conglobata, acne fulminans, etc.), secondary acne (e.g., drug-induced acne, mechanical acne, occupational acne, chloracne, etc.), or other facial rashes due to different conditions (e.g., rosacea, seborrheic dermatitis, solar dermatitis, lupus miliaris disseminatus faciei, psoriasis, eczema, etc.); 2) Facial skin or hair conditions that may interfere with clinical assessments (e.g., prominent beard, sideburns, whiskers, etc.);
Participants have systemic diseases with associated skin lesions: e.g., inflammatory bowel disease (Crohn's disease and ulcerative colitis), SAHA syndrome (seborrhea-acne-hirsutism-androgenetic alopecia syndrome), PCOS syndrome (polycystic ovary syndrome), SAPHO syndrome (synovitis-acne-pustulosis-hyperostosis-osteomyelitis), PAPA syndrome (pyogenic sterile arthritis-pyoderma gangrenosum-acne syndrome), hyperandrogenism-insulin resistance-acanthosis nigricans syndrome, congenital adrenal hyperplasia, etc.;
Trial design
Treatments tested in this trial
- 1% Clascoterone Cream
- Placebo
Treatment groups
692 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov