TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

NCT06748404 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 809201
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

Immunotherapy; Pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.

  6-8 weeks

• To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.

  6-8 weeks

Study Arms (2)

ARM A

EXPERIMENTAL

TriCalm Hydrogel® during cycles 1 and 2

Drug: Tricalm Hydrogel

ARM B

ACTIVE COMPARATOR

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

Drug: Tricalm Hydrogel; Drug: Triamcinolone acetonide 0.1% cream

Interventions

Tricalm Hydrogel DRUG

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.

Also known as: TriCalm Steroid Free Soothing Itch Relief Hydrogel

ARM A; ARM B

Triamcinolone acetonide 0.1% cream DRUG

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

Also known as: Triamcinolone Acetonide

ARM B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older.
• 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).
• Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.
• Preexisting use of oral antihistamines and/or GABA analogs more than 7 days prior to study entry are allowed.

You may not qualify if:

• Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).
• Initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry.
• Presence of open wounds on the skin.
• Presence of pruritus on the face.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Pruritus

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Karen M Yun, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen M Yun, MD

CONTACT

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

Lung Research Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, Medicine

Model Details: This is a phase 2, randomized, open-label, single-center clinical trial that will assess the efficacy of TriCalm Hydrogel® in treating pruritus related to immune checkpoint inhibitors (ICIs). Patients will be randomized 1:1 to receive 2 cycles of TriCalm Hydrogel® versus one cycle of topical corticosteroid followed by one cycle of TriCalm Hydrogel®. A randomized comparison of the change in mean Numeric Rating Scale (NRS) scores between each treatment arm will be performed. Patients will be stratified by 3-week and 4-week ICI cycles. Efficacy and safety outcomes will be assessed over a period of 2 cycles of ICI therapy ranging 6-8 weeks.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)