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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TriCalm Hydrogel®
DrugTriCalm 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.
Triamcinolone acetonide 0.1% cream
DrugTriamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: ARM AExperimental treatment 1 intervention
Group B: ARM BActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.
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.
Time frame
6-8 weeksSecondary outcomes
1
To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.
Change in mean Dermatology Life Quality Index (DLQI) scores after 1 and 2 cycles of TriCalm Hydrogel® for all patients in both treatment arms will be assessed by 95% confidence intervals. Randomized comparison of the change in mean pruritus DLQI scores, after cycle 2, between treatment arms will be assessed by 95% confidence intervals. DLQI is a 10-item questionnaire assessing the impact of pruritus on quality of life in the last 7 days. Responses are scored on a 4-point scale ranging from 0 (not at all or not relevant) to 3 (very much) for a total maximum of 30 points and a minimum of 0 points. Higher total scores correspond to greater impairment in quality of life. DLQI scores will be assessed weekly in this study.
Time frame
6-8 weeks2
To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.
AEs will be graded according to CTCAE version 5.0.
Time frame
6-8 weeksSponsors and contacts
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Source ClinicalTrials.gov