NCT02318654进行中（未招募）4 期
Comparing the Efficacy of Ice Pack Versus Topical EMLA for Pain Control in Laser Axillary Hair Removal: A Randomized Control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain using the SF-MPQ 5 minutes after treatment
研究概览
简要总结
The primary objective of this study is to compare the efficacy of ice pack to topical eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary hair removal.
This study is a pilot study designed to determine feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects are Caucasian or Asian females.
- •Subjects are 18-65 years old.
- •Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair.
- •Subjects are in good health.
- •Subjects can provide informed consent.
- •Subjects have the willingness and the ability to understand and communicate with the investigators.
排除标准
- •Subjects who are allergic to lidocaine or prilocaine.
- •History of methemoglobinemia.
- •History of recurrent petechial or purpuric lesions.
- •Bleeding tendency or coagulopathy.
- •History of laser treatment in axilla.
- •History of keloid or hypertrophic scarring.
- •Pregnant or lactating or intends to become pregnant in the next 3 months.
- •Active skin disease or skin infection in the treatment area.
- •Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders.
- •History of cold urticaria.
- •History of current injury or abnormal skin sensation.
- •Unable to understand the protocol or to give informed consent.
- •Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to subject.
研究组 & 干预措施
Ice Pack
Active Comparator
干预措施: Ice Pack (Other)
Topical EMLA cream
Active Comparator
干预措施: Topical EMLA cream (Drug)
结局指标
主要结局
Pain using the SF-MPQ 5 minutes after treatment
时间窗: 5 mins after laster treatment
Pain using the SF-MPQ immediately after treatment
时间窗: immediately (at 0 min) after laser treatment
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University
研究点 (2)
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