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NCT06748404PHASE2Recruiting

TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

University of California, San Diego

Start Date

3/5/2025

Completion Date

12/1/2028

Summary

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).

Detailed Description

Pruritus is a common immune-related adverse event of immune checkpoint inhibitors (ICI). 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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Patients aged 18 years or older. 2. 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). 3. Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI. 4. Preexisting use of oral antihistamines and/or GABA analogs more than 7 days prior to study entry are allowed. Exclusion Criteria: 1. Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis). 2. Initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry. 3. Presence of open wounds on the skin. 4. Presence of pruritus on the face.

Interventions

DRUG

TriCalm Hydrogel®

DRUG

Triamcinolone acetonide 0.1% cream

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Conditions

Immunotherapy-related Pruritus

Locations

University of California San Diego

La Jolla, California 92037

United States