TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Last updated: February 7, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

2

Condition

Hives (Urticaria)

Rash

Skin Wounds

Treatment

Triamcinolone acetonide 0.1% cream

Tricalm Hydrogel

Clinical Study ID

NCT06748404
809201
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 years or older.

  2. Patients receiving ICIs for hematologic or oncologic malignancies at the MooresCancer Center Infusion Center at UC San Diego. ICIs include CTLA-4 inhibitors (ipilimumab), PD-1 inhibitors (cemiplimab, nivolumab, pembrolizumab) and PD-L1inhibitors (atezolizumab, avelumab, durvalumab).

  3. Patients who develop grade 1-3 pruritus at any time after receiving at least onedose of ICI.

  4. Preexisting use of oral antihistamines and/or GABA analogs more than 7 days prior tostudy entry are allowed.

Exclusion

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 systemiccorticosteroids within 7 days prior to study entry.

  3. Presence of open wounds on the skin.

  4. Presence of pruritus on the face.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Triamcinolone acetonide 0.1% cream
Phase: 2
Study Start date:
January 31, 2025
Estimated Completion Date:
December 31, 2028

Study Description

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.

Connect with a study center

  • University of California San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

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