TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TriCalm Hydrogel®, Triamcinolone acetonide 0.1% cream.
- Who it may be relevant to
- Registry conditions: Immunotherapy-related Pruritus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
Overview
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.
Interventions
- Drug TriCalm Hydrogel®
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. - Drug Triamcinolone acetonide 0.1% cream
Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.
Primary outcome measures
- To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus. [Time frame: 6-8 weeks]
Secondary outcome measures (2)
- To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus. [Time frame: 6-8 weeks]
- To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus. [Time frame: 6-8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of California San Diego — La Jolla
Identifiers
NCT: NCT06748404 · 809201