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

Primary Purpose

Bites and Stings

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Repellent lotion

Repellent Wipe

About this trial

This is an interventional prevention trial for Bites and Stings focused on measuring mosquito

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Louisiana State University, Department of EntomologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Median Complete Protection Time

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05394597

First Posted

June 14, 2021

Last Updated

May 23, 2022

Sponsor

Louisiana State University Health Sciences Center in New Orleans

1. Study Identification

Unique Protocol Identification Number

NCT05394597

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 11, 2021 (Actual)

Primary Completion Date

June 10, 2022 (Anticipated)

Study Completion Date

June 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bites and Stings

Keywords

mosquito

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Repellent lotion

Other Intervention Name(s)

IR3535 Repellent in lotion format

Intervention Description

lotion of the repellent active ingredient IR3535

Intervention Type

Other

Intervention Name(s)

Repellent Wipe

Other Intervention Name(s)

IR3535 Repellent in wipe format

Intervention Description

wipe of the repellent active ingredient IR3535

Primary Outcome Measure Information:

Title

Median Complete Protection Time

Description

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

Time Frame

14 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristen Healy, PhD

Phone

225-578-7386

khealy@lsu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mike Stout, PhD

Phone

225-578-1628

mstout@agcenter.lsu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristen Healy, PhD

Organizational Affiliation

Louisiana State University Health Sciences Center in New Orleans

Official's Role

Principal Investigator

Facility Information:

Facility Name

Louisiana State University, Department of Entomology

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70803

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristen Healy, PhD

Phone

225-578-7386

khealy@lsu.edu

First Name & Middle Initial & Last Name & Degree

Mike Stout, PhD

Phone

225-578-1628

mstout@agcenter.lsu.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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