Determining the Complete Protection Time of an Insect Repellent With 30% Citriodiol® Against Three Species of Ticks.
Primary Purpose
Tick Bites
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Citrepel (Insect Repellent) EPA Reg. No. 84878-2
Sponsored by
About this trial
This is an interventional basic science trial for Tick Bites
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- ARCTEC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Consumer Dose and Tick Repellency
Arm Description
Consumer dose: Dosimetry test of insect repellent application to forearms. Tick repellency: Treatment of forearm with insect repellent and exposure to ticks every 15 minutes for 10 hours.
Outcomes
Primary Outcome Measures
First confirmed crossing
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.
Secondary Outcome Measures
Average consumer dose
The mean dose rate applied by a sample of 25 volunteers, measured as mg/cm2 and converted to volume using the specific gravity of the formulation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03708120
Brief Title
Determining the Complete Protection Time of an Insect Repellent With 30% Citriodiol® Against Three Species of Ticks.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCTEC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
Rhipicephalus sanguineus - The brown dog tick is distributed worldwide, including across the United States. It is the vector of many pathogens, including Rickettsia rickettsia, the causative agent of Rocky Mountain spotted fever, Coxiella burnetii, causative agent of Q fever, Ehrlichia canis, and Rickettsia conorii. Dogs are the primary host for the brown dog tick in each of its life stages, but the tick may also bite humans or other mammals.
Ticks will be sourced from disease-free colonies at Oklahoma State University and housed at the London School of Hygiene & Tropical Medicine, United Kingdom, under optimal environmental conditions of 25 ± 3 °C and greater than or equal to 80% Relative Humidity with a 16:8 hour photoperiod.
Single ticks will be exposed to participants' forearms following standardised treatment of one of the participant's forearms with repellent, in a laboratory setting. The treatment will be based on the dose derived from the dosimetry phase of the study, which will be submitted to EPA for review before proceeding to the repellency phase of testing. The treatment will be randomised to either the left or right arm of each participant for each test. There is no blinding employed since the outcome measures are based on tick behaviour. Twenty-five participants will be required for the consumer dose evaluation and to test the repellent against each of the tick species (preferably with a 50:50 ratio of males to females). Participants will test the product at a single dose against at least one of the three species.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick Bites
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single group trial with the participants acting as their own controls, one arm will be treated with insect repellent, and the other left untreated.
Masking
None (Open Label)
Masking Description
There is no blinding employed since the outcome measures are based on tick behaviour.
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Consumer Dose and Tick Repellency
Arm Type
Experimental
Arm Description
Consumer dose: Dosimetry test of insect repellent application to forearms. Tick repellency: Treatment of forearm with insect repellent and exposure to ticks every 15 minutes for 10 hours.
Intervention Type
Other
Intervention Name(s)
Citrepel (Insect Repellent) EPA Reg. No. 84878-2
Other Intervention Name(s)
Citrapel, Coleman botanicals Insect Repellent
Intervention Description
Citrepel (Insect Repellent) EPA Reg. No. 84878-2 is a pump spray formulation containing the active ingredient Citriodiol®, a tradename for Oil of Lemon Eucalyptus (OLE, Chemical Abstracts Service (CAS) No.: 1245629-80-4). Citriodiol® is derived from Eucalyptus citriodora leaves and contains a minimum of 65% p-Menthane-3,8-diol (PMD, CAS: 42822-86-6) and other constituents occurring naturally in the essential oil source material. The repellent is manufactured by Citrefine International Ltd and will be supplied by them in the pump spray bottle the manufacturer intends to use when the product is marketed with instructions for use on the product label.
Primary Outcome Measure Information:
Title
First confirmed crossing
Description
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.
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
Average consumer dose
Description
The mean dose rate applied by a sample of 25 volunteers, measured as mg/cm2 and converted to volume using the specific gravity of the formulation.
Time Frame
2 hours
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants will report their own gender. The study will aim to enrol approximate equal numbers of males and females.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Logan
Organizational Affiliation
ARCTEC
Official's Role
Study Chair
Facility Information:
Facility Name
ARCTEC
City
London
ZIP/Postal Code
WC1E 7HT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determining the Complete Protection Time of an Insect Repellent With 30% Citriodiol® Against Three Species of Ticks.
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