TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

Conditions

• Immunotherapy-related Pruritus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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).

Key Dates

Start date

Jan 31, 2025

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

28 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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

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

• Karen M Yun, MD
  (858) 822-6100
  [email protected]
• Lung Research Team
  (858) 822-5354
  [email protected]

Locations (1)

Find similar trials in La Jolla, CA