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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Receives a dose of repellent on the lower portion of the leg that is exposed |
|
| Control group | No Intervention | Does not receive a dose of repellent, but subject to similar exposure period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repellent lotion | Other | lotion of the repellent active ingredient IR3535 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Complete Protection Time | the time for each repellent product tested that shows efficacy against mosquito bites | 14 hours |
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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:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Healy, PhD | Contact | 225-578-7386 | khealy@lsu.edu | |
| Mike Stout, PhD | Contact | 225-578-1628 | mstout@agcenter.lsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristen Healy, PhD | Louisiana State University Health Sciences Center in New Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University, Department of Entomology | Recruiting | Baton Rouge | Louisiana | 70803 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2021 | May 23, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2021 | May 23, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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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.
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| Repellent Wipe | Other | wipe of the repellent active ingredient IR3535 |
|
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