Relief From Itching of Mosquito Bites Clinical Study Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in degree of itching rating on a 0-100 VAS.
研究概览
简要总结
The purpose of this study is to determine whether over-the-counter (OTC) use of the ZapperClick device employing the piezo-electricity principle is effective in reducing itching associated with mosquito bites.
详细描述
The ZapperClick is a therapeutic device that employs the piezo-electricity principle to soothe itching and ease the swelling from mosquito and horsefly bites as well as jellyfish and nettle stings. It accomplishes this by discharging 13KV at 0.7mA for 10 microseconds over the area of the bite or sting each time it is activated. In this clinical study, only the indication of reducing itching from mosquito bites will be evaluated. The theory behind the device's effectiveness is that multiple high voltage, low current electrical discharges over a bug bite or sting generates warmth over the immediate area of the bite or sting which inhibits the histamine release, thus relieving the symptoms of itching and swelling arising from the bite or sting. The device is a quick, simple and painless means of reducing the annoying symptoms of mosquito bites.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One lab-induced mosquito bite on the non-dominant forearm
- •Familiarity with an immediate mosquito bite reaction.
- •History of immediately responding to mosquito bites with itching.
- •Willing and able to refrain from consuming anti-histamines, corticosteroids, or Non-Steroid Anti-Inflammatory Drugs (NSAID,) for a time period of 4 half lives of the drug prior to the beginning of the study, and continuing throughout the course of the study.
- •Willing to abstain from the use of insect repellant and/or any treatment other than the test device for the relief of mosquito bite symptoms until after the study.
- •Primary written and spoken language is English.
排除标准
- •No history of prior affliction with mosquito bites.
- •History of lack of reaction to mosquito and/or other insect bites that includes itching.
- •History of hypersensitivity to the bites or stings of mosquitoes, bees or wasps.
- •Presence of mosquito bites or other types of insect bite/stings on any location on the body.
- •Current use of steroids.
- •Use of insect repellants during the week prior to study start.
- •Use of topical agents on the arm during the week prior to study start.
- •Pacemaker, ICD or other implantable heart device.
- •Therapeutic use of any type of electrical stimulation.
- •Epilepsy.
- •Diabetes.
- •Presence of neurological disorder.
- •Prior surgery to the forearm area.
- •Infection or wound in the forearm area.
- •Any skin or other disease or illness that can cause or influence skin itching, such as Psoriasis.
- •Developmental disability or cognitive impairment that impacts the ability to read and/or to understand the content of the informed consent form or the device labeling and/or impacts the ability to read and/or to understand and/or to complete the study case report forms.
- •Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization.
- •Pregnancy or lactation.
- •Involvement in litigation and/or receiving disability benefits related to any kind of disability, injury, or other medical problem.
- •Participation in research over the preceding 90 days.
结局指标
主要结局
Change in degree of itching rating on a 0-100 VAS.
时间窗: 10 minutes
次要结局
- Changes in 0-100 VAS itching ratings, and changes in total area of mosquito bite erythema, across the 24-hour evaluation period.(24 hours)