NCT00958139

Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lyme Disease

Interventions

Type	Name	Description
OTHER	Permethrin	Permethrin 0.5% treatment of clothing one time
OTHER	Placebo	water sprayed on clothing one time

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2009-08-13
• Last updated: 2020-06-04

Locations

1 site across 1 country: United States