TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Description

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).

Conditions

Immunotherapy-related Pruritus

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Study Overview

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Study Details

Study overview

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).

A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Condition
Immunotherapy-related Pruritus
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California San Diego, La Jolla, California, United States, 92037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Diego,

Karen M Yun, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

2028-12