PediculosisNCT00731718
Control of Head Lice Infestations in Children and Adults
A study testing lousebuster in people with Pediculosis, run by Larada Sciences, Inc. at 1 site in United States.
Trial summary
The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pediculosis
- What is being tested?
- lousebuster
- Type of treatment
- Medical device
- How many people
- 543 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2008
- Phase
- Interventional
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be at least 6 years old, male or female Parent to attend treatment Able to comb the hair with no problems
Who cannot join
- Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Control of Head Lice in Children and Adults
The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.
Read the detailed description
Head lice strikes fear into the hearts of parents of school age children. Ridding a child of head lice is one of the most frustrating experiences a parent can face.
The objective of this project is to test whether louse desiccation using our prototype is an effective means of controlling head louse infestations in children.
Children age 6 and over are included in this study.
- Conditions
- Pediculosis
- Being tested
- lousebuster
- Keywords
- Head Lice
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lousebusterDevice
Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of using heated air to kill head lice and their eggs
Measured: Through out
Secondary outcomes (1)
Safety of device
Measured: Through out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PediculosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larada Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dale Clayton, PhD/Biology, Principal investigator, Larada Sciences Inc., University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731718
- Sponsor's protocol ID
- LS/LB-001
- Other IDs
- IRB 008018
- Status last verified
- Aug 2008
- First submitted
- 23 Apr 2008
- Last updated
- 11 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goates BM, Atkin JS, Wilding KG, Birch KG, Cottam MR, Bush SE, Clayton DH. An effective nonchemical treatment for head lice: a lot of hot air. Pediatrics. 2006 Nov;118(5):1962-70. doi: 10.1542/peds.2005-1847.
PubMed 17079567Bush SE, Rock AN, Jones SL, Malenke JR, Clayton DH. Efficacy of the LouseBuster, a new medical device for treating head lice (Anoplura:Pediculidae). J Med Entomol. 2011 Jan;48(1):67-72. doi: 10.1603/me10122.
PubMed 21337950
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Head Lice in Children and Adults
- ClinicalTrials.gov ID
- NCT00731718
- Acronym / sponsor ID
- LS/LB-001
- Conditions
- Pediculosis
- Keywords
- Head Lice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Larada Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Aug 2008 (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.
The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.
Detailed description
Head lice strikes fear into the hearts of parents of school age children. Ridding a child of head lice is one of the most frustrating experiences a parent can face.
The objective of this project is to test whether louse desiccation using our prototype is an effective means of controlling head louse infestations in children.
Children age 6 and over are included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be at least 6 years old, male or female Parent to attend treatment Able to comb the hair with no problems
Key exclusion criteria (1 listed)
- Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation
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 |
|---|---|---|
| lousebusterSubject serves as own control the length of treatment is approximately 30 minutes for full head treatment | Device | – |
Primary outcome
Efficacy of using heated air to kill head lice and their eggs
Time frame: Through out
1 secondary outcome
Safety of device
Time frame: Through out
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2008.
- Background: PubMed 17079567Goates BM, Atkin JS, Wilding KG, Birch KG, Cottam MR, Bush SE, Clayton DH. An effective nonchemical treatment for head lice: a lot of hot air. Pediatrics. 2006 Nov;118(5):1962-70. doi: 10.1542/peds.2005-1847.
- Derived from this study: PubMed 21337950Bush SE, Rock AN, Jones SL, Malenke JR, Clayton DH. Efficacy of the LouseBuster, a new medical device for treating head lice (Anoplura:Pediculidae). J Med Entomol. 2011 Jan;48(1):67-72. doi: 10.1603/me10122.
- National Pediculosis AssociationLink provided by the sponsor.
Related trials for Pediculosis
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
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Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
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.
Dale Clayton, PhD/Biology principal investigator
Larada Sciences Inc., University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lousebuster in people with Pediculosis, run by Larada Sciences, Inc. 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Aug 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of using heated air to kill head lice and their eggs (time frame: Through out). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00731718, which also lists 2 linked publications.
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 11 Aug 2008.