Recruiting

Phase 2

TriCalm Hydrogel®TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Sponsor:

UCLA

Code:

NCT06748404

Conditions

Immunotherapy-related Pruritus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TriCalm Hydrogel®

Triamcinolone acetonide 0.1% cream

Study Details

Brief 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).

Conditions

Immunotherapy-related Pruritus

Study ID

NCT06748404

Start date

Mar 5, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ARM A

TriCalm Hydrogel® during cycles 1 and 2

active comparator: ARM B

Triamcinolone cream during cycle 1 followed by TriCalm Hydrogel® during cycle 2

Interventions

TriCalm Hydrogel®

TriCalm Hydrogel® is a topical gel that allows rapid administration to the affected areas of the skin.

TriCalm Hydrogel® is available over-the-counter and contains the active ingredient, aluminum acetate 0.2%, and inactive ingredient, strontium chloride hexahydrate.

Triamcinolone acetonide 0.1% cream

Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.

Primary outcome measure

To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus. [ Time Frame: 6-8 weeks ]

Central Contacts and Locations

Central contacts

Karen M Yun, MD

(858) 822-6100 k5yun@health.ucsd.edu

Lung Research Team

(858) 822-5354 CancerCTO@health.ucsd.edu

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Karen Yun, MD

858-822-5354 CancerCTO@health.ucsd.edu

Principal Investigator:

Karen Yun, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

Immunotherapy
Pruritus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-30.