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Status unknownNCT05394597Updated May 27, 2022

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

An interventional study of Repellent lotion and Repellent Wipe in Bites and Stings, sponsored by Louisiana State University Health Sciences Center in New Orleans. Status unknown at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-27.

Sponsored by Louisiana State University Health Sciences Center in New Orleans · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bites and Stings

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Keywords

  • mosquito
03

In context

Bites and Stings

112 studies on the registry are indexed under Bites and Stings; 45 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 89 interventional studies indexed under Bites and Stings.

Browse Bites and Stings studies →

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment group

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

    Other: Repellent lotion · Other: Repellent Wipe

  • No intervention
    Control group

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

Interventions

  • OtherRepellent lotion

    lotion of the repellent active ingredient IR3535

    Also known as: IR3535 Repellent in lotion format

  • OtherRepellent Wipe

    wipe of the repellent active ingredient IR3535

    Also known as: IR3535 Repellent in wipe format

06

What researchers measure

Primary outcomes

  1. Median Complete Protection Time

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

    Time frame: 14 hours

07

Study locations

1 of 1 sites recruiting
  • Louisiana State University, Department of Entomology
    Baton Rouge, Louisiana 70803, United States
    Recruiting
08

References and documents

Study documents

  • Study protocol · Apr 1, 2021
  • Informed consent form · May 17, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05394597
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Responsible party
Kristen Healy (Associate Professor, Louisiana State University Health Sciences Center in New Orleans) — Principal investigator
First posted
May 27, 2022
Start date
Jun 11, 2021
Primary completion
Jun 10, 2022 (estimated)
Completion
Jun 10, 2022 (estimated)
Last update
May 27, 2022

Study contacts

Kristen Healy, PhD
Contact
khealy@lsu.edu
225-578-7386
Mike Stout, PhD
Contact
mstout@agcenter.lsu.edu
225-578-1628
Kristen Healy, PhD
principal investigator · Louisiana State University Health Sciences Center in New Orleans

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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