TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
ConditionImmunotherapy-related Pruritus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TriCalm Hydrogel®
- Triamcinolone acetonide 0.1% cream
Treatment groups
28 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov