A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks.
研究概览
简要总结
Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause injection related erythema. This is a randomized controlled cross-over trial of superficial hot and cold modalities to reduce injection site erythema caused by PEG.
详细描述
The most common adverse event associated with this subcutaneously (SC) injected drug is injection site reaction (ISR) including redness and pain.Theoretically, both heat and cold modalities may improve interferon injection tolerance. Warm compress before injection may increase local blood flow and increase rapid systemic absorption, while cold compress afterward may reduce the erythema, edema and pain that often follow SC injections. A trial comparing heat-before and cold-after therapy is warranted to determine the relative effectiveness of these modalities.
Intervention:
Product: Reusable cold and warm compress.
Patients will receive written instructions for microwave heating and freezer cooling of the compress.
Warm compress: Pre-heating in microwave oven, per instructions. Apply warm compress for 5 minutes prior to injection. The initial compress temperature will be about 43 degrees Celsius (range 40-46 degrees Celsius) and slowly decline during application. Administer drug soon after removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Diagnosis of MS made at least 3 months prior based on McDonald criteria.
- •Age 18 or more
- •Ongoing treatment with PEG for 30 days or more at screening
- •No MS exacerbation for 60 days prior to screening.
- •Score of ≥50 on screening ISR Erythema Index
- •Home access to microwave oven and freezer
- •Written informed consent
排除标准
- •Any contraindication to warm or cold compress:
- •Inability to sense temperature change by patient report
- •Metal implant near injection site (e.g. injection near intra-abdominal baclofen pump)
- •History of allergy or intolerance to local heat or cold application
- •Bleeding disorder
- •Concomitant use of any topical prescription medication at injection site
- •Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures)
- •Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
- •Any other serious and/or unstable medical condition
结局指标
主要结局
Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks.
时间窗: 24 hours, 7 days, 14 days
Participants will record the diameter of patch of skin discoloration in millimeters, measuring at the maximum width.
次要结局
- Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days(Change from Baseline in VAS at 24 hours, 7 days, and 14 days.)
- Pain score on the visual analogue scale after 10-minutes.(10 min.)
- Change from baseline in rating of Modified Local Injection Site Reaction Scale(24 hours)
- Erythema score on the Visual Assessment Scale.(Change from Baseline in VAS at 24 hours, 7 days, and 14 days.)
- Level of Comfort Post-Injection Impression of Last 3 Weeks.(18 Weeks)