Determining the Complete Protection Time of an Insect Repellent With 30% Citriodiol® Against Three Species of Ticks.

NCT03708120 | Completed

• 1 other identifier: 593
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Tick Bites

Outcome Measures

Primary Outcomes (1)

• 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.

  10 hours

Secondary Outcomes (1)

• Average consumer dose

  2 hours

Study Arms (1)

Consumer Dose and Tick Repellency

EXPERIMENTAL

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.

Other: Citrepel (Insect Repellent) EPA Reg. No. 84878-2

Interventions

Citrepel (Insect Repellent) EPA Reg. No. 84878-2 OTHER

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.

Also known as: Citrapel, Coleman botanicals Insect Repellent

Consumer Dose and Tick Repellency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants will report their own gender. The study will aim to enrol approximate equal numbers of males and females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARCTEC: lead

Study Sites (1)

ARCTEC

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Tick Bites

Interventions

Insect Repellents

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pesticides; Agrochemicals; Specialty Uses of Chemicals; Toxic Actions

Study Officials

• James G Logan

  ARCTEC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no blinding employed since the outcome measures are based on tick behaviour.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: November 15, 2018
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)