TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

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

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).

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy-related Pruritus
• Intervention / Treatment: Drug: Tricalm Hydrogel; Drug: Triamcinolone acetonide 0.1% cream

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karen M Yun, MD; Phone Number: (858) 822-6100; Email: k5yun@health.ucsd.edu
• Study Contact Backup: Name: Lung Research Team; Phone Number: (858) 822-5354; Email: CancerCTO@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Contact: Karen Yun, MD; Phone Number: (858) 822-5354; Email: CancerCTO@health.ucsd.edu
      • Principal Investigator: Karen Yun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM A; TriCalm Hydrogel® during cycles 1 and 2	Drug: Tricalm Hydrogel; TriCalm Hydrogel® is a topical gel that allows rapid administration to 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.; Other Names: TriCalm Steroid Free Soothing Itch Relief Hydrogel
Active Comparator: ARM B; Triamcinolone cream during cycle 1 followed by Tricalm Hydrogel® during cycle 2	Drug: Tricalm Hydrogel; TriCalm Hydrogel® is a topical gel that allows rapid administration to 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.; Other Names: TriCalm Steroid Free Soothing Itch Relief Hydrogel; Drug: Triamcinolone acetonide 0.1% cream; Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.; Other Names: Triamcinolone Acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.	Efficacy of TriCalm Hydrogel® in reducing the severity of pruritus as defined as change in mean pruritus Numeric Rating Scale (NRS) scores. A randomized comparison of the change in mean pruritus NRS scores after cycle 1 (Arm A, one cycle of TriCalm Hydrogel®; Arm B, one cycle of topical corticosteroid) will be tested between treatment arms. NRS is a single item questionnaire assessing the patient-reported severity of itch at its greatest intensity over the past 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch'. NRS scores will be assessed weekly in this study.	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.	Adverse events (AEs) related to TriCalm Hydrogel®. AEs will be graded according to CTCAE version 5.0. Incidence, description, timing, severity, and relatedness of AEs will be summarized.	6-8 weeks
To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.	Change in mean Dermatology Life Quality Index (DLQI) scores after 1 and 2 cycles of TriCalm Hydrogel® for all patients in both treatment arms will be assessed by 95% confidence intervals. Randomized comparison of the change in mean pruritus DLQI scores, after cycle 2, between treatment arms will be assessed by 95% confidence intervals. DLQI is a 10-item questionnaire assessing the impact of pruritus on quality of life in the last 7 days. Responses are scored on a 4-point scale ranging from 0 (not at all or not relevant) to 3 (very much) for a total maximum of 30 points and a minimum of 0 points. Higher total scores correspond to greater impairment in quality of life. DLQI scores will be assessed weekly in this study.	6-8 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Karen M Yun, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Pruritus
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pruritus; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide
• Other Study ID Numbers: 809201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No