Using TriCalm Hydrogel® to treat itching caused by immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, open-label, single-center study evaluates the effectiveness of TriCalm Hydrogel®, a topical gel containing strontium, in alleviating pruritus associated with immune checkpoint inhibitors (ICIs). The study aims to determine if this treatment can reduce the severity of itching and enhance the quality of life for patients undergoing immunotherapy for cancer. Participants will be monitored for changes in pruritus severity after using the hydrogel compared to standard treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Karen M Yun, MD — University of California, San Diego
• Study coordinator: Karen M Yun, MD
• Email: k5yun@health.ucsd.edu
• Phone: (858) 822-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.