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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | TriCalm Hydrogel® during cycles 1 and 2 |
|
| ARM B | Active Comparator | Triamcinolone cream during cycle 1 followed by TriCalm Hydrogel® during cycle 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriCalm Hydrogel® | Drug | TriCalm 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen M Yun, MD | Contact | (858) 822-6100 | k5yun@health.ucsd.edu | |
| Lung Research Team | Contact | (858) 822-5354 | CancerCTO@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen M Yun, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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.
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|
| Triamcinolone acetonide 0.1% cream | Drug | Triamcinolone acetonide 0.1% cream is a topical steroid cream that will be applied directly to the skin. |
|
|
| 6-8 weeks |
| To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus. | AEs will be graded according to CTCAE version 5.0. | 6-8 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |