TriCalm Hydrogel® for Immunotherapy-Related Itching
This study is testing TriCalm Hydrogel®, a topical gel, to see if it can reduce itching (pruritus) caused by immunotherapy treatments. TriCalm Hydrogel® contains aluminum acetate and strontium chloride hexahydrate. It will be compared to Triamcinolone acetonide 0.1% cream, a steroid cream. We are looking for 28 adults aged 18 or older who are receiving specific immunotherapy drugs (like PD-1, PD-L1, or CTLA-4 inhibitors) for cancer at Moores Cancer Center. The main goal is to see how well TriCalm Hydrogel® reduces itching severity over 6-8 weeks. The study status is currently unclear.
- Study design
- This is a phase 2, randomized, open-label study involving about 28 participants at a single center.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be evaluated for itching severity over 6-8 weeks.
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TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Karen M Yun, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego
Who to contact
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What this trial measures
- To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.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.