TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

University of California San Diego

Status and phase: Enrolling; Phase 2

Conditions: Immunotherapy-related Pruritus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06748404

809201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

ARM A

Experimental group

Description:

TriCalm Hydrogel® during cycles 1 and 2

Treatment:

Drug: Tricalm Hydrogel

ARM B

Active Comparator group

Description:

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

Treatment:

Drug: Triamcinolone acetonide 0.1% cream

Drug: Tricalm Hydrogel