Using TriCalm Hydrogel® to treat itching caused by immunotherapy
A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
PHASE2 · University of California, San Diego · NCT06748404
This study is testing if TriCalm Hydrogel® can help reduce itching for cancer patients receiving immunotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Drugs / interventions | ipilimumab, cemiplimab, nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, immunotherapy |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06748404 on ClinicalTrials.gov |
What this trial studies
This phase 2, randomized, open-label, single-center study evaluates the effectiveness of TriCalm Hydrogel®, a topical gel containing strontium, in alleviating pruritus associated with immune checkpoint inhibitors (ICIs). The study aims to determine if this treatment can reduce the severity of itching and enhance the quality of life for patients undergoing immunotherapy for cancer. Participants will be monitored for changes in pruritus severity after using the hydrogel compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older receiving immune checkpoint inhibitors for cancer treatment who develop mild to moderate pruritus.
Not a fit: Patients with primary skin disorders causing pruritus or those with pruritus on the face may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients experiencing pruritus due to immunotherapy.
How similar studies have performed: Previous studies have shown that topical strontium salts can effectively reduce pruritus, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California
- University of California San Diego — La Jolla, California, United States (RECRUITING)
Study contacts
- Principal investigator: Karen M Yun, MD — University of California, San Diego
- Study coordinator: Karen M Yun, MD
- Email: k5yun@health.ucsd.edu
- Phone: (858) 822-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immunotherapy-related Pruritus, Immunotherapy, Pruritus