[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100318576":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":45,"locations":46,"responsibleParty":60,"collaborators":45,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":45,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":45,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":45,"overallStatus":82,"whyStopped":45,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Sun Pharmaceutical Industries, Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Tretinoin cream 0.1%","EXPERIMENTAL","Once daily at home, to apply the entire affected areas of the face.",[13],"Drug: Tretinoin cream 0.1%",{"label":15,"type":16,"description":11,"interventionNames":17},"RETIN-A® Cream","ACTIVE_COMPARATOR",[18],"Drug: RETIN-A® Cream",{"label":20,"type":21,"description":11,"interventionNames":22},"Vehicle of the test product","PLACEBO_COMPARATOR",[23],"Drug: Vehicle of the test product",[25,31,35],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)",[9],[30],"Tretinoin",{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"RETIN-A® (Tretinoin) Cream (Valeant)",[15],[30],{"type":26,"name":20,"description":36,"armGroupLabels":37,"otherNames":38},"Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)",[20],[39],"Placebo",[41],{"name":42,"affiliation":43,"role":44},"Zaidoon A Al-Zubaidy","Catawba Research","STUDY_DIRECTOR",null,[47],{"facility":48,"status":45,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":45},"Catawba Research, LLC","Charlotte","North Carolina","28217","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-80.84313,35.22709,{"lat":58,"lon":57},{"type":61,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100318576","early-phase-1-to-evaluate-the-therapeutic-equivalence-and-safety-of-tretinoin-cream-01-and-rld-in-the-treatment-of-acne-vulgaris-100318576",false,"NCT03427554","To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris","A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris","Inclusion Criteria:\n\n* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.\n* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).\n* Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.",true,"ALL","12 Years","40 Years",{"count":74,"type":75},455,"ACTUAL","INTERVENTIONAL",[78],"EARLY_PHASE1","Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.",[81],"Acne Vulgaris","COMPLETED","2018-05-16",{"date":85,"type":75},"2018-05-18",{"date":87,"type":75},"2017-08-21",{"date":89,"type":75},"2018-01-26",{"name":5,"class":6},1]