[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460987":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":46,"locations":47,"responsibleParty":61,"collaborators":46,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":46,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":46,"enrollmentInfo":73,"targetDuration":46,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":46,"overallStatus":82,"whyStopped":46,"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},"Halobetasol Propionate and Tazarotene Topical lotion 0.01%\u002F0.045%","EXPERIMENTAL","The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks",[13],"Drug: Halobetasol Propionate and Tazarotene Lotion 0.01%\u002F0.045%",{"label":15,"type":16,"description":11,"interventionNames":17},"Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%\u002F0.045%","ACTIVE_COMPARATOR",[18],"Drug: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%\u002F0.045%",{"label":20,"type":21,"description":11,"interventionNames":22},"Placebo Control","PLACEBO_COMPARATOR",[23],"Drug: Placebo",[25,32,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Halobetasol Propionate and Tazarotene Lotion 0.01%\u002F0.045%","The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.",[9],[31],"Test Product",{"type":26,"name":15,"description":28,"armGroupLabels":33,"otherNames":34},[15],[35],"Reference Product",{"type":26,"name":37,"description":28,"armGroupLabels":38,"otherNames":39},"Placebo",[20],[40],"Vehicle",[42],{"name":43,"affiliation":44,"role":45},"Zaidoon A. Al-Zubaidy","Catawba Research","STUDY_DIRECTOR",null,[48],{"facility":49,"status":46,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":46},"Catawba Research, LLC","Charlotte","North Carolina","28217","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-80.84313,35.22709,{"lat":59,"lon":58},{"type":62,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100460987","early-phase-1-a-study-comparing-halobetasol-propionate-and-tazarotene-topical-lotion-0010045-to-duobrii-lotion-halobetasol-propionate-and-tazarotene-lotion-0010045-reference-listed-drug-in-the-treatment-of-moderate-to-severe-plaque-psoriasis-100460987",false,"NCT05282771","A Study Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%\u002F0.045% to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%\u002F0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.","A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%\u002F0.045% (Taro Pharmaceuticals U.S.A., Inc.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%\u002F0.045% (Reference Listed Drug) and Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Healthy male or non-pregnant female aged ≥ 18 years\n* Subjects must have provided IRB approved written informed consent\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* Subjects with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving at least 3% and no more than 12% of the body surface area (BSA). Affected areas should not include the axillae, face, scalp, soles, palms, and intertriginous areas\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.\n* Females of childbearing potential who do not agree to utilize an adequate form of contraception.\n* Subjects with a known hypersensitivity to tazarotene, halobetasol propionate, other corticosteroids, or to any ingredients in the study drugs.\n* Subjects with current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.",true,"ALL","18 Years",{"count":74,"type":75},402,"ACTUAL","INTERVENTIONAL",[78],"EARLY_PHASE1","To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%\u002F0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%\u002F0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.",[81],"Plaque Psoriasis","COMPLETED","2022-03-15",{"date":85,"type":75},"2022-03-16",{"date":87,"type":75},"2021-04-16",{"date":89,"type":75},"2022-02-10",{"name":5,"class":6},1]