[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361562":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":119,"collaborators":19,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":19,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":19,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":46,"whyStopped":19,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Bausch Health Americas, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IDP-122 Lotion","EXPERIMENTAL","Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 6 to 11 years 11 months) will apply IDP-122 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.",[13],"Drug: IDP-122 Lotion",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Topical",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Alison Magnotti-Nagel","STUDY_DIRECTOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","9085418664","alison.magnotti-nagel@bauschhealth.com",[30,44,54,64,73,79,89,99,109],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":19},"Bausch Site 11","TERMINATED","Fountain Valley","California","92708","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-117.95367,33.70918,{"lat":42,"lon":41},{"facility":45,"status":46,"city":47,"state":34,"zip":48,"country":36,"countryCode":37,"cosmosGeoPoint":49,"geoPoint":53,"contacts":19},"Bausch Site 2","RECRUITING","Thousand Oaks","91320",{"type":39,"coordinates":50},[51,52],-118.83759,34.17056,{"lat":52,"lon":51},{"facility":55,"status":46,"city":56,"state":57,"zip":58,"country":36,"countryCode":37,"cosmosGeoPoint":59,"geoPoint":63,"contacts":19},"Bausch Site 07","Doral","Florida","33166",{"type":39,"coordinates":60},[61,62],-80.35533,25.81954,{"lat":62,"lon":61},{"facility":65,"status":46,"city":66,"state":57,"zip":67,"country":36,"countryCode":37,"cosmosGeoPoint":68,"geoPoint":72,"contacts":19},"Bausch Site 3","Miami","33125",{"type":39,"coordinates":69},[70,71],-80.19366,25.77427,{"lat":71,"lon":70},{"facility":74,"status":32,"city":66,"state":57,"zip":75,"country":36,"countryCode":37,"cosmosGeoPoint":76,"geoPoint":78,"contacts":19},"Bausch Site 06","33155",{"type":39,"coordinates":77},[70,71],{"lat":71,"lon":70},{"facility":80,"status":32,"city":81,"state":82,"zip":83,"country":36,"countryCode":37,"cosmosGeoPoint":84,"geoPoint":88,"contacts":19},"Bausch Site 05","Spartanburg","South Carolina","29303",{"type":39,"coordinates":85},[86,87],-81.93205,34.94957,{"lat":87,"lon":86},{"facility":90,"status":32,"city":91,"state":92,"zip":93,"country":36,"countryCode":37,"cosmosGeoPoint":94,"geoPoint":98,"contacts":19},"Bausch Site 1","Spokane","Washington","99216",{"type":39,"coordinates":95},[96,97],-117.42908,47.65966,{"lat":97,"lon":96},{"facility":100,"status":46,"city":101,"state":19,"zip":19,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":19},"Bausch Site 12","Santo Domingo","Dominican Republic","DO",{"type":39,"coordinates":105},[106,107],-69.89232,18.47186,{"lat":107,"lon":106},{"facility":110,"status":32,"city":111,"state":19,"zip":19,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":19},"Bausch Site 4","Panama City","Panama","PA",{"type":39,"coordinates":115},[116,117],-79.51973,8.9936,{"lat":117,"lon":116},{"type":120,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100361562","phase-4-a-safety-and-pharmacokinetics-study-of-idp-122-lotion-in-pediatric-participants-with-plaque-psoriasis-100361562",false,"NCT03987763","A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis","A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Is 6 to 16 years 11 months of age at time of informed consent\u002Fassent obtained.\n* Verbal and written informed consent\u002Fassent obtained from the participant and\u002For parent or legal guardian.\n* Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.\n* Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation.\n* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.\n* Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is \\>18 μg\u002FdL at the Screening visit.\n* Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n* Has a history of adrenal disease.\n* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.\n* Is pregnant, nursing an infant, or planning a pregnancy during the study period.\n* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device.\n* Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and\u002For treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.\n* Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.\n* Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.","ALL","6 Years","17 Years",{"count":132,"type":133},45,"ESTIMATED","INTERVENTIONAL",[136],"PHASE4","This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.",[139],"Psoriasis",[141],"Plaque psoriasis","2025-08-26",{"date":144,"type":145},"2025-08-27","ACTUAL",{"date":147,"type":145},"2019-10-22",{"date":149,"type":133},"2026-06",{"name":5,"class":6},9]