TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
University of California, San Diego
28 participants
Jan 31, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- Patients aged 18 years or older.
- 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).
- Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.
- Preexisting use of oral antihistamines and/or GABA analogs more than 7 days prior to study entry are allowed.
Exclusion Criteria4
- Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).
- Initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry.
- Presence of open wounds on the skin.
- Presence of pruritus on the face.
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Interventions
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.
Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06748404