Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT06748404
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a phase 2, randomized, open-label, single-center clinical trial that will assess the efficacy of TriCalm Hydrogel® in treating pruritus related to immune checkpoint inhibitors (ICIs). Patients will be randomized 1:1 to receive 2 cycles of TriCalm Hydrogel® versus one cycle of topical corticosteroid followed by one cycle of TriCalm Hydrogel®. A randomized comparison of the change in mean Numeric Rating Scale (NRS) scores between each treatment arm will be performed. Patients will be stratified by 3-week and 4-week ICI cycles. Efficacy and safety outcomes will be assessed over a period of 2 cycles of ICI therapy ranging 6-8 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.', 'timeFrame': '6-8 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.', 'timeFrame': '6-8 weeks', 'description': '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': 'To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.', 'timeFrame': '6-8 weeks', 'description': 'Adverse events (AEs) related to TriCalm Hydrogel®. AEs will be graded according to CTCAE version 5.0. Incidence, description, timing, severity, and relatedness of AEs will be summarized.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Pruritus'], 'conditions': ['Immunotherapy-related Pruritus']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or 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/or systemic corticosteroids within 7 days prior to study entry.\n3. Presence of open wounds on the skin.\n4. Presence of pruritus on the face.'}, 'identificationModule': {'nctId': 'NCT06748404', 'briefTitle': 'TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus', 'orgStudyIdInfo': {'id': '809201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM A', 'description': 'TriCalm Hydrogel® during cycles 1 and 2', 'interventionNames': ['Drug: Tricalm Hydrogel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ARM B', 'description': 'Triamcinolone cream during cycle 1 followed by Tricalm Hydrogel® during cycle 2', 'interventionNames': ['Drug: Tricalm Hydrogel', 'Drug: Triamcinolone acetonide 0.1% cream']}], 'interventions': [{'name': 'Tricalm Hydrogel', 'type': 'DRUG', 'otherNames': ['TriCalm Steroid Free Soothing Itch Relief Hydrogel'], 'description': 'TriCalm Hydrogel® is a topical gel that allows rapid administration to areas of the skin. TriCalm Hydrogel® is available over-the-counter and contains the active ingredient, aluminum acetate 0.2%, and inactive ingredient, strontium chloride hexahydrate.', 'armGroupLabels': ['ARM A', 'ARM B']}, {'name': 'Triamcinolone acetonide 0.1% cream', 'type': 'DRUG', 'otherNames': ['Triamcinolone Acetonide'], 'description': 'Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.', 'armGroupLabels': ['ARM B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Yun, MD', 'role': 'CONTACT', 'email': 'CancerCTO@health.ucsd.edu', 'phone': '(858) 822-5354'}, {'name': 'Karen Yun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Karen M Yun, MD', 'role': 'CONTACT', 'email': 'k5yun@health.ucsd.edu', 'phone': '(858) 822-6100'}, {'name': 'MCC Clinical Trials Office', 'role': 'CONTACT', 'email': 'CancerCTO@health.ucsd.edu', 'phone': '(858) 822-5354'}], 'overallOfficials': [{'name': 'Karen M Yun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor, Medicine', 'investigatorFullName': 'Karen Yun', 'investigatorAffiliation': 'University of California, San Diego'}}}}