[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100319024":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":41,"locations":42,"responsibleParty":56,"collaborators":41,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":41,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":41,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":41,"overallStatus":78,"whyStopped":41,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sun Pharmaceutical Industries, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Tretinoin cream, 0.05%","ACTIVE_COMPARATOR","Apply once a day application, under at-home use conditions.",[13],"Drug: Tretinoin cream, 0.05%",{"label":15,"type":10,"description":11,"interventionNames":16},"RETIN-A® (tretinoin) cream, 0.05%",[17],"Drug: RETIN-A® (tretinoin) cream, 0.05%",{"label":19,"type":20,"description":11,"interventionNames":21},"Vehicle of the test product","PLACEBO_COMPARATOR",[22],"Drug: Vehicle of the test product",[24,29,32],{"type":25,"name":9,"description":9,"armGroupLabels":26,"otherNames":27},"DRUG",[9],[28],"Tretinoin",{"type":25,"name":15,"description":15,"armGroupLabels":30,"otherNames":31},[15],[28],{"type":25,"name":19,"description":19,"armGroupLabels":33,"otherNames":34},[19],[35],"placebo",[37],{"name":38,"affiliation":39,"role":40},"Natalie Yantovskiy","Taro Pharmaceuticals Inc","STUDY_DIRECTOR",null,[43],{"facility":44,"status":41,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":41},"Catawba Research, LLC","Charlotte","North Carolina","28217","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-80.84313,35.22709,{"lat":54,"lon":53},{"type":57,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100319024","early-phase-1-to-evaluate-the-therapeutic-equivalence-and-safety-of-tretinoin-cream-005-and-rld-in-the-treatment-of-acne-vulgaris-100319024",false,"NCT03433378","To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris","A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% 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) (per Table 1 below).\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation\n* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.",true,"ALL","12 Years","40 Years",{"count":70,"type":71},700,"ACTUAL","INTERVENTIONAL",[74],"EARLY_PHASE1","Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.",[77],"Acne Vulgaris","COMPLETED","2018-05-16",{"date":81,"type":71},"2018-05-18",{"date":83,"type":71},"2017-08-04",{"date":85,"type":71},"2018-01-26",{"name":5,"class":6},1]