Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00958139

Enrollment

Registered

2009-08-13

Start date

2008-06-30

Completion date

2008-10-31

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Disease

Keywords

Lyme disease, tick

Brief summary

Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease? This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.

Detailed description

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.

Interventions

OTHERPermethrin

Permethrin 0.5% treatment of clothing one time

OTHERPlacebo

water sprayed on clothing one time

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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) * Informed consent

Exclusion criteria

* Contraindication, allergy or previous reaction to permethrin * Inability of subject or surrogate (e.g., parent if \< 18 years of age) to provide informed consent

Design outcomes

Primary

Measure	Time frame
Incidence of Lyme disease	Day <=70

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026