Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Pruritus Visual Analogue Scale (VAS) Score
研究概览
简要总结
The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.
详细描述
Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Ability to sign informed consent document
- •Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel
- •Patients with a diagnosis of CTCL who have intractable pruritis
- •Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
- •Patients on chemo/immunotherapy with drug induced rash
排除标准
- •Patients currently undergoing radiotherapy
- •Patients currently receiving oral steroids
- •Patients who are unable to apply topical medications
研究组 & 干预措施
CTCL group
Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel.
干预措施: StrataCTX® gel (Device)
结局指标
主要结局
Change in Pruritus Visual Analogue Scale (VAS) Score
时间窗: Screening through 3 months
The primary objective of this study is to determine whether StrataCTX® gel is effective as a supportive therapy for cutaneous reactions treated with topical steroids as the standard of care. This objective will be measured by the Pruritus Visual Analogue Scale, which measures self-reported itching on a scale of 0 (no itching) (better outcome) to 10 (worst imaginable itch).
次要结局
- Change in SKINDEX-16 Quality of Life (QOL) Score(Screening through 3 months)
- Change in the Rate of Primary Skin Reactions(Screening through 3 months)
- Change in Topical Steroid Use(Day 30 through 3 months)
研究者
Larisa Geskin, MD
Principal Investigator
Columbia University