A Single Group Trial to Determine the Complete Protection Time of an Insect Repellent Formulation Containing 30% Citriodiol® (Oil of Lemon Eucalyptus) Against Three Species of Ticks.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- First confirmed crossing
研究概览
简要总结
This study evaluates the length of time an insect repellent product can protect against three species of ticks. Participants will have one arm treated with the repellent, and throughout the next 10 hours, ticks will be given the opportunity to crawl up the treated arm. The test will stop after 10 hours or when the repellent stops working whichever occurs sooner.
详细描述
This is a single group trial with the participants acting as their own controls. The study is split into two parts; the first to determine a typical consumer dose when applied to repel ticks, and the second to evaluate the longevity of that consumer dose against three tick species.
To determine the typical consumer dose, twenty-five volunteers will be required to apply the repellent product from final consumer ready pump spray bottle to their forearm. Each volunteer will be asked to read the label and apply the repellent according to the instructions to their forearm. They will repeat the application three times. The amount applied by each subject across the three applications will be averaged, and then the average amount applied by each subject will be averaged to arrive at a "typical consumer dose". This typical consumer dose will be used as the application rate for the tick repellent efficacy trial. Three species are required by the EPA to demonstrate the effectiveness of a repellent. The following tick species have been chosen from the list of five species recommended by the EPA.
Ixodes scapularis - Also known as blacklegged ticks or deer ticks, this species is one of the principal vectors of Lyme disease. They are found in eastern and northern Midwest of the United States. The lifecycle takes approximately two years during which the tick develops from egg to larva, to nymph and finally adult. Larvae, nymphs and adults will all blood feed. Larvae usually feed from smaller mammals and birds, whilst nymphs and adults feed on larger mammals such as deer and humans.
Amblyomma americanum - The Lone Star Tick is found in the eastern United States and in Mexico. This species of hard tick can be a vector of human ehrlichiosis, tularaemia, and may trigger an allergy to the carbohydrate alpha gal found in mammalian meat.
Dermacentor variabilis - The American dog tick is usually found in central and eastern areas of the United States. Adults preferentially feed on large mammals such as dogs and humans, however immature stages will also feed on humans if the opportunity arises. They are the most common vector of Rocky Mountain spotted fever, and can also transmit tularaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
There is no blinding employed since the outcome measures are based on tick behaviour.
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
- •Able to understand and comply with the study procedures
- •Able and willing to give fully informed consent
- •Male or female
- •Aged 18 to 65 years
- •Non-smoker or willing to refrain from smoking for 24 hours prior to and during each test
- •Able to stand unsupported for periods of at least 5 minutes
- •Willing to have hair clipped from the wrist area (3cm upwards from wrist line)
排除标准
- •If female, pregnant, nursing or intending to become pregnant, during the time period of the study.
- •Not in good general health, including:
- •serious cardiac disorder (whether active or inactive)
- •serious respiratory disorder
- •compromised immune system
- •history of anaphylaxis
- •Localised skin disorders affecting the forearms where the product will be applied (including but not restricted to open wounds, eczema, psoriasis, dermatitis or open wounds)
- •Participation in another clinical intervention study (excluding biting insect challenge studies*) in the previous 3 months
- •Participation in another biting insect challenge study* in the previous 72 hours
- •Known or suspected history of tick bite allergies
- •Known allergy to Oil of Lemon Eucalyptus, or any ingredients of the test product
- •Known phobia of ticks or tick bites
- •Employees and spouses of employees of the Study Sponsor (Citrefine Inc.), arctec, and those directly line managed by Professor James Logan
- •Students of the Professor James Logan, or any other faculty members involved in the study.
结局指标
主要结局
First confirmed crossing
时间窗: 10 hours
The time between application of the repellent product and the time at which 1 tick crosses in its entirety into the treated skin and remains there for at least 1 minute, followed within 30 minutes by a second confirmatory crossing.
次要结局
- Average consumer dose(2 hours)