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