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

NCT05394597 | Unknown DMC

• 1 other identifier: 4370
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bites and Stings

Keywords

mosquito

Outcome Measures

Primary Outcomes (1)

• Median Complete Protection Time

  the time for each repellent product tested that shows efficacy against mosquito bites

  14 hours

Study Arms (2)

Treatment group

EXPERIMENTAL

Receives a dose of repellent on the lower portion of the leg that is exposed

Other: Repellent lotion; Other: Repellent Wipe

Control group

NO INTERVENTION

Does not receive a dose of repellent, but subject to similar exposure period

Interventions

Repellent lotion OTHER

lotion of the repellent active ingredient IR3535

Also known as: IR3535 Repellent in lotion format

Treatment group

Repellent Wipe OTHER

wipe of the repellent active ingredient IR3535

Also known as: IR3535 Repellent in wipe format

Treatment group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University, Department of Entomology

Baton Rouge, Louisiana, 70803, United States

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Kristen Healy, PhD

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Healy, PhD

CONTACT

225-578-7386; khealy@lsu.edu

Mike Stout, PhD

CONTACT

225-578-1628; mstout@agcenter.lsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Treatment versus control. 13 with repellent and 2 without, for 15 subjects. Median Complete Protection Time for each repellent product tested against mosquitos for prevention of biting.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: May 27, 2022
• Study Start: June 11, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)