NCT06748404

TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Immunotherapy-related Pruritus

Interventions

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

Timeline

• Start date: 2025-01-31
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-12-27
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study