A Randomized, Double-Blind, Crossover Study Comparing Pliaglis™ (Lidocaine and Tetracaine) Cream 7%/7% to Placebo Cream When Applied for 60 Minutes in the Treatment of Patients With Postherpetic Neuralgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pain will be rated using the Numeric Pain Rating Scale (NPRS). Patients will rate: Worst pain over the last 24 hours, Least pain over the last 24 hours, Average pain over the last 24 hours, Present pain intensity.
研究概览
简要总结
Pliaglis™ (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. When applied to intact skin, Pliaglis provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin.
Pliaglis is currently approved in the United States for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, and facial laser resurfacing.
This study will evaluate lidocaine and tetracaine cream 7%/7% for the treatment of pain associated with postherpetic neuralgia (PHN).
详细描述
The objectives of the study are 1) to compare the clinical efficacy of lidocaine and tetracaine cream 7%/7% with placebo cream in the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and 2) to monitor the nature and frequency of adverse events following a single, 60-minute application of lidocaine and tetracaine cream 7%/7% and placebo cream.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of PHN.
- •Painful PHN areas not located on the face, eye, or in the hair.
- •At least 3 months post-vesicle crusting.
排除标准
- •Has broken skin at the target treatment site.
- •Is currently on certain prescription medications.
- •Doesn't meet criteria due to physical exam findings or medical history.
- •Female that is pregnant, breastfeeding, or of childbearing potential and not practicing adequate birth control.
研究组 & 干预措施
1
干预措施: lidocaine and tetracaine cream 7%/7% (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Pain will be rated using the Numeric Pain Rating Scale (NPRS). Patients will rate: Worst pain over the last 24 hours, Least pain over the last 24 hours, Average pain over the last 24 hours, Present pain intensity.
时间窗: 24 hours after treatment
Area of allodynia will be mapped at baseline and at the treatment sessions.
时间窗: 1-2 weeks between study treatments
Intensity of allodynia
时间窗: Baseline, 4 hours, 9 hours, 24 hours after treatment
Patient global impression of change.
时间窗: 9 & 24 hours after treatment
次要结局
未报告次要终点