Head LicePhase 2NCT02213055
Pediatric Head Lice Study Product Comparison
A Phase 2 study testing LICEMD and Standard Head lice product in people with Head Lice, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population. To evaluate the safety of LiceMD in a pediatric population. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Head Lice
- What is being tested?
- LICEMD and Standard Head lice product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject Inclusion Criteria
- Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.
- Male or female child; age 3 - 12
- Willing to participate in study, and parent/guardian sign informed consent
- Parent/guardian must be able to read and follow directions and complete all questionnaires
- For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study.
Who cannot join
- No live lice, only eggs.
- Less than three live lice observed with less than ten viable eggs
- No hair on the head
- Buzz cut or crew cut
- Use of other lice treatment or home remedy lice treatment within the past 4 weeks
- Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events
- Currently taking an antibiotic
- Does not follow instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
- To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
- To evaluate the safety of LiceMD in a pediatric population.
Read the detailed description
Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.
- Conditions
- Head Lice
- Being tested
- LICEMD, Standard Head lice product
- Keywords
- 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.
LICEMDDrug
Also called Generic Name: Dimethicone
Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.
Standard Head lice productDrug
Also called permethrin (5%), malathion (0.5%), lindane (1%)
The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.
| Study group | Role | What they receive |
|---|---|---|
| LICEMD | Experimental | Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Receives: Drug: LICEMD |
| Standard Head lice product | Active comparator | Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study. Receives: Drug: Standard Head lice product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Free of Live Head Lice and Free of Viable Eggs
A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.
At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.
Measured: Day after first treatment and Day 14 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startMay 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head LiceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Rosen, MD, Principal investigator, Hackensack Meridian HealthJeffrey Boscamp, MD, Study director, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213055
- Sponsor's protocol ID
- Pro00000685
- Status last verified
- Jun 2016
- First submitted
- 7 Aug 2014
- Last updated
- 29 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.
Publications
Ihde ES, Boscamp JR, Loh JM, Rosen L. Safety and efficacy of a 100% dimethicone pediculocide in school-age children. BMC Pediatr. 2015 Jun 20;15:70. doi: 10.1186/s12887-015-0381-0.
PubMed 26092045
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
- ClinicalTrials.gov ID
- NCT02213055
- Acronym / sponsor ID
- Pro00000685
- Conditions
- Head Lice
- Keywords
- Lice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
- To evaluate the safety of LiceMD in a pediatric population.
Detailed description
Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LICEMD | Experimental | Drug: LICEMDInfested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. |
| Standard Head lice product | Active comparator | Drug: Standard Head lice productParents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject Inclusion Criteria
- Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.
- Male or female child; age 3 - 12
- Willing to participate in study, and parent/guardian sign informed consent
- Parent/guardian must be able to read and follow directions and complete all questionnaires
Key exclusion criteria (8 listed)
- No live lice, only eggs.
- Less than three live lice observed with less than ten viable eggs
- No hair on the head
- Buzz cut or crew cut
- Use of other lice treatment or home remedy lice treatment within the past 4 weeks
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 |
|---|---|---|
| LICEMDAlso: Generic Name: DimethiconeParents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. | Drug | LICEMD |
| Standard Head lice productAlso: permethrin (5%), malathion (0.5%), lindane (1%)The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat. | Drug | Standard Head lice product |
Primary outcome
Number of Participants Free of Live Head Lice and Free of Viable Eggs
Time frame: Day after first treatment and Day 14 of study
A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14. At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26092045Ihde ES, Boscamp JR, Loh JM, Rosen L. Safety and efficacy of a 100% dimethicone pediculocide in school-age children. BMC Pediatr. 2015 Jun 20;15:70. doi: 10.1186/s12887-015-0381-0.
- Individual participant dataSharing planned: Yes. The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.
Related trials for Head Lice
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Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
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Recruiting
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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.
Lawrence Rosen, MD principal investigator
Hackensack Meridian Health
Jeffrey Boscamp, MD study director
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LICEMD and Standard Head lice product in people with Head Lice, run by Hackensack Meridian Health 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 6 inclusion and 8 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 29 Jul 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Free of Live Head Lice and Free of Viable Eggs (time frame: Day after first treatment and Day 14 of study). 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 NCT02213055, which also lists 1 linked publication.
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 29 Jul 2016.