A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ARM B
Triamcinolone cream during cycle 1 followed by TriCalm Hydrogel® during cycle 2
干预措施: Triamcinolone acetonide 0.1% cream (Drug)
ARM A
TriCalm Hydrogel® during cycles 1 and 2
干预措施: TriCalm Hydrogel® (Drug)
ARM B
Triamcinolone cream during cycle 1 followed by TriCalm Hydrogel® during cycle 2
干预措施: TriCalm Hydrogel® (Drug)
结局指标
主要结局
To evaluate the efficacy of TriCalm Hydrogel® in reducing the severity of immunotherapy-related pruritus.
时间窗: 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.
次要结局
- To evaluate the efficacy of TriCalm Hydrogel® in improving the quality of life in patients with immunotherapy-related pruritus.(6-8 weeks)
- To evaluate the safety of TriCalm Hydrogel® in patients with immunotherapy-related pruritus.(6-8 weeks)
研究者
Karen Yun
Assistant Clinical Professor, Medicine
University of California, San Diego