[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06748404":3,"trial-entities:NCT06748404":99,"trial-summary:NCT06748404":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":87,"overall_officials":95,"references":97,"see_also_links":98},"NCT06748404","809201","TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus","A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus","RECRUITING","2028-12","2026-06","2026-06-30","2025-03-05","University of California, San Diego","OTHER",true,"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).","Pruritus is a common immune-related adverse event of immune checkpoint inhibitors (ICI).\n\nThis 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 ICIs. Topical strontium salts have been found to reduce the duration and severity of histaminergic and nonhistaminergic pruritus. The investigators hypothesize that TriCalm Hydrogel® will be effective in reducing the severity of immunotherapy-related pruritus and improve quality of life.",[19],"Immunotherapy-related Pruritus",[21,22],"Immunotherapy","Pruritus","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"PHASE2",{"count":28,"type":29},28,"ESTIMATED",[31,40],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"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.",[36,37],"ARM A","ARM B",[39],"TriCalm Steroid Free Soothing Itch Relief Hydrogel",{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Triamcinolone acetonide 0.1% cream","Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.",[37],[45],"Triamcinolone Acetonide",[47],{"measure":48,"description":49,"timeFrame":50},"To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.","Efficacy of TriCalm Hydrogel® in reducing the severity of pruritus as defined as change in mean pruritus Numeric Rating Scale (NRS) scores.\n\nA randomized comparison of the change in mean pruritus NRS scores after cycle 1 (Arm A, one cycle of TriCalm Hydrogel®; Arm B, one cycle of topical corticosteroid) will be tested between treatment arms.\n\nNRS is a single item questionnaire assessing the patient-reported severity of itch at its greatest intensity over the past 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch'. NRS scores will be assessed weekly in this study.","6-8 weeks",[52,55],{"measure":53,"description":54,"timeFrame":50},"To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.","Change in mean Dermatology Life Quality Index (DLQI) scores after 1 and 2 cycles of TriCalm Hydrogel® for all patients in both treatment arms will be assessed by 95% confidence intervals.\n\nRandomized comparison of the change in mean pruritus DLQI scores, after cycle 2, between treatment arms will be assessed by 95% confidence intervals.\n\nDLQI is a 10-item questionnaire assessing the impact of pruritus on quality of life in the last 7 days. Responses are scored on a 4-point scale ranging from 0 (not at all or not relevant) to 3 (very much) for a total maximum of 30 points and a minimum of 0 points. Higher total scores correspond to greater impairment in quality of life. DLQI scores will be assessed weekly in this study.",{"measure":56,"description":57,"timeFrame":50},"To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.","AEs will be graded according to CTCAE version 5.0.","ALL","18 Years",null,false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":84},"University of California San Diego","La Jolla","California","92037","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Karen Yun, MD","CONTACT","858-822-5354","CancerCTO@health.ucsd.edu",{"name":78,"role":83},"PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},32.84727,-117.2742,[88,92],{"name":89,"role":79,"phone":90,"email":91},"Karen M Yun, MD","(858) 822-6100","k5yun@health.ucsd.edu",{"name":93,"role":79,"phone":94,"email":81},"Lung Research Team","(858) 822-5354",[96],{"name":89,"affiliation":13,"role":83},[],[],{"nct_id":4,"conditions":100,"biomarkers":101},[22],[],{"nct_id":4,"found":15,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is a phase 2, randomized, open-label study involving about 28 participants at a single center.","completed","TriCalm Hydrogel® for Immunotherapy-Related Itching","This study is testing TriCalm Hydrogel®, a topical gel, to see if it can reduce itching (pruritus) caused by immunotherapy treatments. TriCalm Hydrogel® contains aluminum acetate and strontium chloride hexahydrate. It will be compared to Triamcinolone acetonide 0.1% cream, a steroid cream. We are looking for 28 adults aged 18 or older who are receiving specific immunotherapy drugs (like PD-1, PD-L1, or CTLA-4 inhibitors) for cancer at Moores Cancer Center. The main goal is to see how well TriCalm Hydrogel® reduces itching severity over 6-8 weeks. The study status is currently unclear.","Participants will be evaluated for itching severity over 6-8 weeks.",92,"Not specified in the trial record.","Not stated in the trial record.",[33,41],"v2"]