Suspended

Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

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What is being tested

Permethrin

+ Placebo

Other
Who is being recruted

Vector Borne Diseases+6

+ Bacterial Infections and Mycoses

+ Bacterial Infections

From 14 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2008
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2008

Actual date on which the first participant was enrolled.

This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease. Subjects (N=200) will be recruited from camp staff to participate in the study and screened by inclusion and exclusion criteria.Qualifying subjects will be randomized to either the treatment (N=100) or non-treatment arm (N=100). Subjects in the treatment arm will have their scout shorts, pants, and socks sprayed with 0.5% permethrin and allowed to dry. Subjects in the non-treatment arm will have their scout shorts, pants, and socks sprayed with water and allowed to dry. Subjects will then be followed over the summer camping season to see if they develop Lyme disease. At 70 days, all subjects will have their Lyme titers rechecked to ensure that all cases of Lyme disease were documented. Following the 70 day visit, there will be an assessment of the final study outcomes.

Official TitlePassive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
NCT00958139
Principal SponsorUniversity of Minnesota
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesBacterial Infections and MycosesBacterial InfectionsBorrelia InfectionsInfectionsLyme DiseaseSpirochaetales InfectionsGram-Negative Bacterial InfectionsTick-Borne Diseases

Criteria

5 inclusion criteria required to participate
Summer camp staff at Tomahawk Scout Reservation
Works in an outdoor environment
Sleeps in an outdoor environment (platform tent)
Present for the entire camp season (June - August)
Show More Criteria
2 exclusion criteria prevent from participating
Contraindication, allergy or previous reaction to permethrin
Inability of subject or surrogate (e.g., parent if < 18 years of age) to provide informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
0.5% permethrin sprayed one time on uniform shorts, pants, and socks

Group II

Sham
Water sprayed on uniform shorts, pants, and socks

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tomahawk Scout Camp

Rice Lake, United StatesOpen Tomahawk Scout Camp in Google Maps
SuspendedOne Study Center