Bites and StingsNCT05394597
Field Evaluation of Two Topically Applied Insect Repellent Products Containing IR3535 Against Mosquitos in Louisiana
A study testing Repellent lotion and Repellent Wipe in people with Bites and Stings, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bites and Stings
- What is being tested?
- Repellent lotion and Repellent Wipe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Louisiana State University, Department of Entomology
Baton Rouge, Louisiana, 70803
Kristen Healy, PhD, 225-578-7386, khealy@lsu.edu
Mike Stout, PhD, 225-578-1628, mstout@agcenter.lsu.edu
About this study
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.
- Conditions
- Bites and Stings
- Being tested
- Repellent lotion, Repellent Wipe
- Keywords
- mosquito
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repellent lotionOther
Also called IR3535 Repellent in lotion format
lotion of the repellent active ingredient IR3535
Repellent WipeOther
Also called IR3535 Repellent in wipe format
wipe of the repellent active ingredient IR3535
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Receives a dose of repellent on the lower portion of the leg that is exposed Receives: Other: Repellent lotion; Other: Repellent Wipe |
| Control group | No intervention | Does not receive a dose of repellent, but subject to similar exposure period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Complete Protection Time
the time for each repellent product tested that shows efficacy against mosquito bites
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start11 Jun 2021
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bites and StingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Healy, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Kristen Healy, PhD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394597
- Sponsor's protocol ID
- 4370
- Status last verified
- May 2022
- First submitted
- 14 Jun 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Evaluation of Two Topically Applied Insect Repellent Products Containing IR3535 Against Mosquitos in Louisiana
- ClinicalTrials.gov ID
- NCT05394597
- Acronym / sponsor ID
- 4370
- Conditions
- Bites and Stings
- Keywords
- mosquito
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Repellent lotion, Other: Repellent WipeReceives 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repellent lotionAlso: IR3535 Repellent in lotion formatlotion of the repellent active ingredient IR3535 | Other | Treatment group |
| Repellent WipeAlso: IR3535 Repellent in wipe formatwipe of the repellent active ingredient IR3535 | Other | Treatment group |
Primary outcome
Median Complete Protection Time
Time frame: 14 hours
the time for each repellent product tested that shows efficacy against mosquito bites
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Healy, PhD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repellent lotion and Repellent Wipe in people with Bites and Stings, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen Healy, PhD (225-578-7386, khealy@lsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Complete Protection Time (time frame: 14 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.