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NCT Number: NCT06748404

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).

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Key information

Conditions

Immunotherapy-related Pruritus Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California San Diego

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

Karen Yun, MD

CONTACT

[email protected]

858-822-5354

Karen Yun, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

TriCalm Hydrogel®

Drug

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.

Other names: TriCalm Steroid Free Soothing Itch Relief Hydrogel

Triamcinolone acetonide 0.1% cream

Drug

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

Other names: Triamcinolone Acetonide

Primary outcomes

  1. To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.

    Time frame: 6-8 weeks

    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.

Secondary outcomes

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

    Time frame: 6-8 weeks

    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.

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

    Time frame: 6-8 weeks

    AEs will be graded according to CTCAE version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen M Yun, MD

CONTACT

[email protected]

(858) 822-6100

Lung Research Team

CONTACT

[email protected]

(858) 822-5354

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 27, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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