[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547094":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":50,"collaborators":30,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":30,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":30,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clascoterone Cream 1%","EXPERIMENTAL","Clascoterone Cream 1% (Winlevi)",[13],"Drug: Clascoterone",{"label":15,"type":16,"description":17,"interventionNames":18},"Vehicle cream","PLACEBO_COMPARATOR","Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.",[19],"Drug: Vehicle cream",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Clascoterone","Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",[9],[27],"Winlevi (brand name)",{"type":22,"name":15,"description":17,"armGroupLabels":29,"otherNames":30},[15],null,[32],{"facility":33,"status":34,"city":35,"state":30,"zip":30,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Shuyang Zhao","CONTACT","13123927303","zhaoshuyang@wsh.3sbio.com",{"type":51,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100547094","phase-3-efficacy-and-safety-of-clascoterone-cream-1-in-facial-acne-vulgaris-100547094",false,"NCT06403501","Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris","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","Inclusion Criteria:\n\n* 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);\n* Male or female, 12 years of age or older;\n* 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.\n\nExclusion Criteria:\n\n* Subject has greater than two (2) facial nodules;\n* Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;\n* Subject has used topical and systemic anti-acne medications or therapies;\n* Subject has received hormonal therapy for acne treatment;\n* Subject has used a skincare product with acne removal effect;\n* Subject has other serious underlying diseases such as mental illness or malignant tumors;\n* Subject has any of the clinically significant laboratory test indicators at screening;\n* Subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles;\n* Subject engaged in drug abuse or excessive alcohol intake;\n* Subject has uncontrolled hypertension; Subject has poorly controlled diabetes;\n* 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;\n* Subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment;\n* Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.","ALL","12 Years",{"count":62,"type":63},692,"ESTIMATED","INTERVENTIONAL",[66],"PHASE3","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.",[69],"Acne Vulgaris",[69],"2025-07-03",{"date":73,"type":74},"2025-07-09","ACTUAL",{"date":76,"type":74},"2024-05-20",{"date":78,"type":63},"2026-10",{"name":5,"class":6},1]