A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
University of California, San Diego
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).
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 primar…
Interventions
- DrugTricalm Hydrogel
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.
- DrugTriamcinolone acetonide 0.1% cream
Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.
Location
- University of California San DiegoLa Jolla, California