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TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

RecruitingPhase 2Ages 18 Years - anyAllUniversity of California, San Diego
NCT06748404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • TriCalm Hydrogel®
  • Triamcinolone acetonide 0.1% cream
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Where

1 site
University of California San Diego
La Jolla, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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