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Recruiting NCT06748404

TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Conditions: Immunotherapy-related Pruritus

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 28
Sponsor: University of California, San Diego

Location: University of California San Diego La Jolla California

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06748404). StuddyBuddy aggregates publicly available trial information.