Clinical trial NCT06748404: TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
Official title: A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Immunotherapy-related Pruritus
Keywords: Immunotherapy
Pruritus
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase 2, randomized, open-label, single-center clinical trial that will assess the efficacy of TriCalm Hydrogel® in treating pruritus related to immune checkpoint inhibitors (ICIs). Patients will be randomized 1:1 to receive 2 cycles of TriCalm Hydrogel® versus one cycle of topical corticosteroid followed by one cycle of TriCalm Hydrogel®. A randomized comparison of the change in mean Numeric Rating Scale (NRS) scores between each treatment arm will be performed. Patients will be stratified by 3-week and 4-week ICI cycles. Efficacy and safety outcomes will be assessed over a period of 2 cycles of ICI therapy ranging 6-8 weeks.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.
timeFrame: 6-8 weeks
Secondary outcomes:
measure: To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.
timeFrame: 6-8 weeks
measure: To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Karen M Yun, MD
role: PRINCIPAL_INVESTIGATOR
References: