Lyme DiseasePhase 3NCT00958139
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
A Phase 3 study testing Permethrin in people with Lyme Disease, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- Permethrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication, allergy or previous reaction to permethrin
- Inability of subject or surrogate (e.g., parent if < 18 years of age) to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Permethrin, Placebo
- Keywords
- Lyme disease, tick
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermethrinOther
Permethrin 0.5% treatment of clothing one time
PlaceboOther
water sprayed on clothing one time
| Study group | Role | What they receive |
|---|---|---|
| Permethrin treatment of clothing | Experimental | 0.5% permethrin sprayed one time on uniform shorts, pants, and socks Receives: Other: Permethrin |
| Placebo | Sham comparator | Water sprayed on uniform shorts, pants, and socks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Lyme disease
Measured: Day <=70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionOct 2008
Why it stopped: After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R. Boulware, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958139
- Sponsor's protocol ID
- 0804M3101
- Status last verified
- Jun 2020
- First submitted
- 12 Aug 2009
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
- ClinicalTrials.gov ID
- NCT00958139
- Acronym / sponsor ID
- 0804M3101
- Conditions
- Lyme Disease
- Keywords
- Lyme disease, tick
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permethrin treatment of clothing | Experimental | Other: Permethrin0.5% permethrin sprayed one time on uniform shorts, pants, and socks |
| Placebo | Sham comparator | Other: PlaceboWater sprayed on uniform shorts, pants, and socks |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication, allergy or previous reaction to permethrin
- Inability of subject or surrogate (e.g., parent if < 18 years of age) to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PermethrinPermethrin 0.5% treatment of clothing one time | Other | Permethrin treatment of clothing |
| Placebowater sprayed on clothing one time | Other | Placebo |
Primary outcome
Incidence of Lyme disease
Time frame: Day <=70
Results and safety
The study was stopped early (reason given: After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R. Boulware, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Permethrin in people with Lyme Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Lyme disease (time frame: Day <=70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020; AzTrials last refreshed its copy on 4 Nov 2026.