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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00958139
Other study ID # 0804M3101
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 2008
Est. completion date October 2008

Study information

Verified date June 2020
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 61
Est. completion date October 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Permethrin
Permethrin 0.5% treatment of clothing one time
Placebo
water sprayed on clothing one time

Locations

Country Name City State
United States Tomahawk Scout Camp Rice Lake Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Lyme disease Day <=70
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