Comparison Trial Between Two Repellent Products and a Positive Control Against Culicoides Nubeculosus Midges

NCT04028180 | Completed

• 1 other identifier: 928
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison trial between two repellent products and a positive control against Culicoides nubeculosus midges. A single-centre laboratory setting study using healthy volunteers to test two insect repellent products and a positive control product against Culicoides nubeculosus midges. The test products are designed for use by the general public in areas where midge biting is likely.

Conditions

Midge Bites

Outcome Measures

Primary Outcomes (1)

• Median Complete Protection Time

  The time between application of the repellent product and the occurrence of the first probe or bite in a 1 minute test, followed by a confirmatory probe or bite within 30 minutes.

  12 hours

Secondary Outcomes (1)

• Protective Efficacy

  12 hours

Study Arms (1)

Midge Repellency

EXPERIMENTAL

Treatment of forearm with insect repellent and exposure to midges every 1 hour for 12 hours

Other: p-Menthane,3-8-diol (PMD) Topical Repellent; Other: Picaridin Topical Repellent

Interventions

p-Menthane,3-8-diol (PMD) Topical Repellent OTHER

p-Menthane,3-8-diol (PMD) is a recommended active ingredient, which has been evaluated for safe use by the U.S. Environmental Protection Agency (USEPA)1. According to the USEPA laboratory exposure of animals to the active ingredient, PMD, this resulted in no adverse effects except eye irritation. The eye irritation potential of the finished product formulation has not been studied; therefore as a precaution, the products will be handled in the same way as the active ingredient. The researcher and participant must wear eye protection during application of the product and the potential for eye irritation is described in the Participant Information Sheet. . Participants will be excluded if they have a known allergy to any of the product ingredients, or any skin condition, which may affect their reaction to the product. There isn't a relevant intervention type hence why other is specified. It is to deter mosquitoes landing on the skin of a human.

Also known as: NEO-PART PMD-XLTM (40% PMD) or NEO-PART PMD-XLTM (35% PMD)

Midge Repellency

Picaridin Topical Repellent OTHER

Icaridin (trade names include Picaridin) is a known mosquito and midge repellent active ingredient. The active ingredient, Picaridin, has been classified as potentially mildly irritating/uncomfortable to the eyes - participants and researcher will wear safety glasses during handling of the products and the participants will be warned about the potential for irritation during the Informed Consent Procedure. Participants will also be excluded if they have a known allergy to any of the product ingredients, or any skin condition which may affect their reaction to the product. There isn't a relevant intervention type hence why other is specified. It is to deter mosquitoes landing on the skin of a human.

Also known as: Smidge (20% Picaridin)

Midge Repellency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give fully informed consent;
• Able to understand and comply with the study procedures;
• Consider themselves to be in good general health;
• Male or female;
• Aged 18 to 65 years;
• Non-smokers or willing to refrain for 12 hours prior to and during each test;
• Willing to undergo a bite test with Culicoides nubeculosus midges with up to 72 hour follow-up.

You may not qualify if:

• Suspected or known to be sensitive or allergic to midge bites;
• Participated in an interventional study (other than a biting insect challenge study) in the previous 3 months;
• Participated in a biting insect challenge study in the previous 72 hours;
• Aware of having any cardiovascular or respiratory disorder (whether active or inactive) (e.g. asthma);
• Individuals with localized skin disorders affecting the forearm;
• Allergic to any of the test product ingredients;
• Extensive tattooing or other conditions of the forearm which would make interpretation of the bite test results difficult;
• Women who are pregnant, nursing or intending to become pregnant;
• Previous anaphylaxis;
• Aware of having a compromised immune system;(an immune system that is temporarily or permanently incapable of working at full capacity);
• Phobia of flying insects;
• Travelled to a mosquito-borne disease endemic area in the last 3 months.

Sponsors & Collaborators

• ARCTEC: lead

Study Sites (1)

Arctec at London School of Hygiene & Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Interventions

Myelin Proteolipid Protein; picaridin

Intervention Hierarchy (Ancestors)

Proteolipids; Membrane Lipids; Lipids; Myelin Proteins; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins

Study Officials

• James Logan, PhD

  ARCTEC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a single-centre, single-arm study with all participants testing one or more products at one dose. The control for each test was an untreated arm. There was no blinding or randomisation employed, since the outcome measures were based on midge behaviour. Repellent product testing took place in a laboratory setting using 15 participants, with a minimum of 3 of either gender per repellent product. Each participant tested at least one single product at one dose.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: November 19, 2018
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

GB (1)