RECRUITING

TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Talk to us

Conditions

Immunotherapy-related PruritusImmunotherapyPruritus

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-01-31
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06748404

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients aged 18 years or older.
  2. 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. 3. Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.
  4. 4. Preexisting use of oral antihistamines and/or GABA analogs more than 7 days prior to study entry are allowed.
  1. 1. Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).
  2. 2. Initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry.
  3. 3. Presence of open wounds on the skin.
  4. 4. Presence of pruritus on the face.

Contacts and Locations

Study Contact

Karen M Yun, MD
CONTACT
(858) 822-6100
k5yun@health.ucsd.edu
MCC Clinical Trials Office
CONTACT
(858) 822-5354
CancerCTO@health.ucsd.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Diego

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Immunotherapy
  • Pruritus

Additional Relevant MeSH Terms

  • Immunotherapy-related Pruritus