A Phase 3 interventional study of Permethrin and Placebo in Lyme Disease, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 14 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Minnesota · Phase 3, Interventional, and Prevention
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.
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.
91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.
This study's enrollment of 61 is below the median of 100 across 49 interventional studies indexed under Lyme Disease.
Browse Lyme Disease studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.5% permethrin sprayed one time on uniform shorts, pants, and socks
Other: Permethrin
Water sprayed on uniform shorts, pants, and socks
Other: Placebo
Permethrin 0.5% treatment of clothing one time
water sprayed on clothing one time
Incidence of Lyme disease
Time frame: Day <=70
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Minnesota