[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361562":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":32,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":136,"collaborators":18,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":18,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":18,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":63,"whyStopped":18,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Bausch Health Americas, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes","On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-122 Lotion analytes.","0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose",[14],{"measure":15,"description":16,"timeFrame":17},"Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression","An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of ≤18 micrograms\u002Fdeciliter (μg\u002FdL) at the end of the study.","Week 8",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[31],"Drug: IDP-122 Lotion",[33],{"type":34,"name":27,"description":35,"armGroupLabels":36,"otherNames":18},"DRUG","Topical",[27],[38],{"name":39,"affiliation":5,"role":40},"Alison Magnotti-Nagel","STUDY_DIRECTOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":18,"email":45},"CONTACT","9085418664","alison.magnotti-nagel@bauschhealth.com",[47,61,71,81,90,96,106,116,126],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":18},"Bausch Site 11","TERMINATED","Fountain Valley","California","92708","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-117.95367,33.70918,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":51,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":18},"Bausch Site 2","RECRUITING","Thousand Oaks","91320",{"type":56,"coordinates":67},[68,69],-118.83759,34.17056,{"lat":69,"lon":68},{"facility":72,"status":63,"city":73,"state":74,"zip":75,"country":53,"countryCode":54,"cosmosGeoPoint":76,"geoPoint":80,"contacts":18},"Bausch Site 07","Doral","Florida","33166",{"type":56,"coordinates":77},[78,79],-80.35533,25.81954,{"lat":79,"lon":78},{"facility":82,"status":63,"city":83,"state":74,"zip":84,"country":53,"countryCode":54,"cosmosGeoPoint":85,"geoPoint":89,"contacts":18},"Bausch Site 3","Miami","33125",{"type":56,"coordinates":86},[87,88],-80.19366,25.77427,{"lat":88,"lon":87},{"facility":91,"status":49,"city":83,"state":74,"zip":92,"country":53,"countryCode":54,"cosmosGeoPoint":93,"geoPoint":95,"contacts":18},"Bausch Site 06","33155",{"type":56,"coordinates":94},[87,88],{"lat":88,"lon":87},{"facility":97,"status":49,"city":98,"state":99,"zip":100,"country":53,"countryCode":54,"cosmosGeoPoint":101,"geoPoint":105,"contacts":18},"Bausch Site 05","Spartanburg","South Carolina","29303",{"type":56,"coordinates":102},[103,104],-81.93205,34.94957,{"lat":104,"lon":103},{"facility":107,"status":49,"city":108,"state":109,"zip":110,"country":53,"countryCode":54,"cosmosGeoPoint":111,"geoPoint":115,"contacts":18},"Bausch Site 1","Spokane","Washington","99216",{"type":56,"coordinates":112},[113,114],-117.42908,47.65966,{"lat":114,"lon":113},{"facility":117,"status":63,"city":118,"state":18,"zip":18,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":18},"Bausch Site 12","Santo Domingo","Dominican Republic","DO",{"type":56,"coordinates":122},[123,124],-69.89232,18.47186,{"lat":124,"lon":123},{"facility":127,"status":49,"city":128,"state":18,"zip":18,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":18},"Bausch Site 4","Panama City","Panama","PA",{"type":56,"coordinates":132},[133,134],-79.51973,8.9936,{"lat":134,"lon":133},{"type":137,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"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":149,"type":150},45,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156],"Psoriasis",[158],"Plaque psoriasis","2025-08-26",{"date":161,"type":162},"2025-08-27","ACTUAL",{"date":164,"type":162},"2019-10-22",{"date":166,"type":150},"2026-06",{"name":5,"class":6},9]