TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

a study on Immunotherapy Pruritus

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Karen M Yun, MD (ucsd)

Description

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).

Official Title

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

Details

Pruritus is a common immune-related adverse event of immune checkpoint inhibitors (ICI).

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 ICIs. Topical strontium salts have been found to reduce the duration and severity of histaminergic and nonhistaminergic pruritus. The investigators hypothesize that TriCalm Hydrogel® will be effective in reducing the severity of immunotherapy-related pruritus and improve quality of life.

Keywords

Immunotherapy-related Pruritus, Immunotherapy, Pruritus, Triamcinolone, Triamcinolone Acetonide, Triamcinolone hexacetonide, Triamcinolone diacetate, Tricalm Hydrogel, Triamcinolone acetonide 0.1% cream

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at University of California Health

  • Karen M Yun, MD (ucsd)
    Assistant Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 9 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06748404
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 28 study participants
Last Updated