[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573601":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":68,"collaborators":42,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":42,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":42,"enrollmentInfo":80,"targetDuration":42,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A","EXPERIMENTAL","TriCalm Hydrogel® during cycles 1 and 2",[13],"Drug: TriCalm Hydrogel®",{"label":15,"type":16,"description":17,"interventionNames":18},"ARM B","ACTIVE_COMPARATOR","Triamcinolone cream during cycle 1 followed by TriCalm Hydrogel® during cycle 2",[13,19],"Drug: Triamcinolone acetonide 0.1% cream",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","TriCalm Hydrogel®","TriCalm Hydrogel® is a topical gel that allows rapid administration to the affected areas of the skin.\n\nTriCalm Hydrogel® is available over-the-counter and contains the active ingredient, aluminum acetate 0.2%, and inactive ingredient, strontium chloride hexahydrate.",[9,15],[27],"TriCalm Steroid Free Soothing Itch Relief Hydrogel",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Triamcinolone acetonide 0.1% cream","Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.",[15],[33],"Triamcinolone Acetonide",[35],{"name":36,"affiliation":5,"role":37},"Karen M Yun, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","(858) 822-6100",null,"k5yun@health.ucsd.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Lung Research Team","(858) 822-5354","CancerCTO@health.ucsd.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of California San Diego","RECRUITING","La Jolla","California","92037","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-117.2742,32.84727,{"lat":61,"lon":60},[64,67],{"name":65,"role":40,"phone":66,"phoneExt":42,"email":47},"Karen Yun, MD","858-822-5354",{"name":65,"role":37,"phone":42,"phoneExt":42,"email":42},{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Karen Yun","Assistant Clinical Professor, Medicine","100573601","phase-2-tricalm-hydrogel-in-the-treatment-of-immunotherapy-related-pruritus-100573601",false,"NCT06748404","TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus","A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus","Inclusion Criteria:\n\n1. Patients aged 18 years or older.\n2. Patients receiving ICIs for hematologic or oncologic malignancies at the Moores Cancer Center Infusion Center at UC San Diego. ICIs include CTLA-4 inhibitors (ipilimumab), PD-1 inhibitors (cemiplimab, nivolumab, pembrolizumab) and PD-L1 inhibitors (atezolizumab, avelumab, durvalumab).\n3. Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.\n4. Preexisting use of oral antihistamines and\u002For GABA analogs more than 7 days prior to study entry are allowed.\n\nExclusion Criteria:\n\n1. Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).\n2. Initiation of any new oral or topical antipruritic medications and\u002For systemic corticosteroids within 7 days prior to study entry.\n3. Presence of open wounds on the skin.\n4. Presence of pruritus on the face.","ALL","18 Years",{"count":81,"type":82},28,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","This is a phase 2, randomized, open-label, single-center study that will assess the efficacy of TriCalm Hydrogel®, a topical gel containing strontium, for treating pruritus related to immune checkpoint inhibitors (ICIs).",[88],"Immunotherapy-related Pruritus",[90,91],"Immunotherapy","Pruritus","2026-06-25",{"date":94,"type":95},"2026-06-30","ACTUAL",{"date":97,"type":95},"2025-03-05",{"date":99,"type":82},"2028-12",{"name":5,"class":6},1]