Field Evaluation of Two Topically Applied Insect Repellent Products Containing IR3535 Against Mosquitos in Louisiana

To determine the efficacy and duration of protection of two topically applied insect repellent products at preventing landing by mosquitos. The study will follow the EPA Product Performance Test Guidelines1. It is intended to test the products against natural populations of mosquito species of public health importance within the genera Aedes, Anopheles, and Culex, and to replace data from one site previously tested in Florida with data from a site in Louisiana with adequate landing pressure from target mosquito species of public health relevance.

Study Overview

• Status: Recruiting
• Conditions: Bites and Stings
• Intervention / Treatment: Other: Repellent lotion; Other: Repellent Wipe

Detailed Description

A single-site field setting study using healthy volunteers to test two insect repellent product formulations (lotion, and wipe) against mosquitos.

Subjects will have repellent applied to one lower limb at a standardised dose rate to account for skin area. They will then expose this area only in a field site where mosquitos are recorded landing at a rate of 5 mosquitos per 5 minute or higher. The exposure period will last five minutes and all mosquitos landing on the exposed skin will be collected using an aspirator. 5 minute exposure periods will be repeated every half hour for 14 hours for the lotion and 13 hours for the wipe, or until median CPT can be established by more than half of subjects reaching treatment failure.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Healy, PhD; Phone Number: 225-578-7386; Email: khealy@lsu.edu
• Study Contact Backup: Name: Mike Stout, PhD; Phone Number: 225-578-1628; Email: mstout@agcenter.lsu.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70803
      • Recruiting
      • Louisiana State University, Department of Entomology
      • Contact: Kristen Healy, PhD; Phone Number: 225-578-7386; Email: khealy@lsu.edu
      • Contact: Mike Stout, PhD; Phone Number: 225-578-1628; Email: mstout@agcenter.lsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able and willing to give fully informed consent;
• Male or female;
• Aged 18 to 55 years;

• Consider themselves to be in good general health, and specifically:

  • Not aware of having any cardiovascular or respiratory disorder (whether active or inactive)
  • No previous anaphylaxis
  • Not aware of having a compromised immune system
• Non-smokers or willing to refrain for 24 hours prior to and during each test;
• Willing to undergo a mosquito attraction test (putting an arm into a cage of mosquitos)
• Able to speak and understand English
• Able to stand outside for periods of at least 5 minutes at a time

• Able to understand and comply with the study procedures, including:

  • Willing to complete mosquito landing/aspirating training
  • Able to withstand exposing the lower leg to mosquitos for periods of at least 5 minutes at a time
  • Able to operate an aspirator

Exclusion Criteria:

• Participated in any other intervention study in the previous 3 months
• Participated in a biting insect test as part of the current study in the previous 72 hours
• Employees, managers, and spouses of employees of the LSU and of the study Sponsor (LivFul, Inc.)
• Students of the Study Director or any other LSU faculty/researchers involved in the study
• Individuals suspected or known to be sensitive or allergic to, or phobic of, mosquito bites
• Women who are pregnant, nursing or intending to become pregnant during the course of the study
• Individuals with localized skin disorders or problems affecting the legs (such as eczema, psoriasis, or atopic dermatitis) or open cuts or scrapes
• Individuals with known or suspected allergy or sensitivity to the test product or any of its ingredients, or any insect repellent products
• Individuals who are not attractive to mosquitos during mosquito attractiveness test
• Individuals who have signs or symptoms related to COVID-19, have tested positive for COVID-19 within the last 15 days, or have had contact (within 6 feet for a total of 15 minutes or more) with someone who has tested positive for COVID-19 in the last 14 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Receives a dose of repellent on the lower portion of the leg that is exposed	Other: Repellent lotion; lotion of the repellent active ingredient IR3535; Other Names: IR3535 Repellent in lotion format; Other: Repellent Wipe; wipe of the repellent active ingredient IR3535; Other Names: IR3535 Repellent in wipe format
No Intervention: Control group; Does not receive a dose of repellent, but subject to similar exposure period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Complete Protection Time	the time for each repellent product tested that shows efficacy against mosquito bites	14 hours

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Kristen Healy, PhD, Louisiana State University Health Sciences Center in New Orleans

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Anticipated): June 10, 2022
• Study Completion (Anticipated): June 10, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: mosquito
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings
• Other Study ID Numbers: 4370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No