Head LicePhase 4NCT00995124
Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
A Phase 4 study testing NeutraLice Lotion, NeutraLice Advance Solution and Moov Head Lice Solution in people with Head Lice, run by Altman Biomedical Consulting Pty. Ltd. at 1 site in Australia.
Trial summary
The purpose of this study is to compare the ovicidal activity of three head lice treatment products. The study population will consist of Queensland primary school-aged children (Grades 1 - 7) who have at least 20 live eggs on the hair and who have not used any head lice product in the four weeks prior to the study. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Lice
- What is being tested?
- NeutraLice Lotion, NeutraLice Advance Solution and Moov Head Lice Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2009to Dec 2009
- Phase
- Phase 4
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female primary school-aged children.
- Presence of at least 20 live head lice eggs on the hair. The presence of live head lice eggs will be determined from a visual inspection of the hair.
- Parent / Guardian have given written informed consent to their child's participation in the trial.
Who cannot join
- History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
- Treatment with any head lice product in the 4 weeks prior to participation in this trial.
- Treatment with hair dyes and bleaches within 4 weeks prior to participation in this trial.
- Presence of scalp disease(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Assessor Blind, Parallel Group, Comparative Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
The purpose of this study is to compare the ovicidal activity of three head lice treatment products.
The study population will consist of Queensland primary school-aged children (Grades 1 - 7) who have at least 20 live eggs on the hair and who have not used any head lice product in the four weeks prior to the study.
Enrollment will continue to achieve 30 subjects in each treatment group (total of 90 subjects).
Read the detailed description
Subjects will be examined for the presence of head louse eggs. Those subjects who have at least 20 live eggs will be randomised into one of 3 treatment groups: NeutraLice Lotion, NeutraLice Advance or Moov Head Lice Solution treatment groups.
Pre-treatment: 10 eggs will be removed from the head by cutting the single hair with the live egg attached, before the treatment.
Treatment: The subject will then receive a single treatment application according to manufacturers instructions. Then the treatment will be washed from the hair as per the manufacturer's instructions.
Post-treatment: At least 10 treated (live) eggs will be removed from the head by cutting the single hair with the egg attached, after the treatment.
All of the eggs will be held in an incubator for 14 days. The proportion of eggs which hatch after 14 days will be compared for the pre-treatment and post-treatment eggs. Demographic data will be collected for each subject (hair type, hair colour, hair length, subject age, subject sex) to investigate the affect of hair type on ovicidal efficacy.
- Conditions
- Head Lice
- Being tested
- NeutraLice Lotion, NeutraLice Advance Solution, Moov Head Lice Solution
- Keywords
- ovicide, head lice infestation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeutraLice LotionDrug
Head lice topical application to be applied once for 10 minutes.
NeutraLice Advance SolutionDrug
head lice application to be applied once for 10 minutes
Moov Head Lice SolutionDrug
Single application for head lice with 10 min application time.
| Study group | Role | What they receive |
|---|---|---|
| NeutraLice Lotion | Experimental | Single application of head lice product. Receives: Drug: NeutraLice Lotion |
| NeutraLice Advance | Experimental | single application of head lice product Receives: Drug: NeutraLice Advance Solution |
| Moov Head Lice Solution | Active comparator | Single application for head lice with 10 min application time. Receives: Drug: Moov Head Lice Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovicidal efficacy index (OEI) The proportion of treated eggs hatched in-vitro divided by the proportion of pre-treated eggs hatched in-vitro expressed as a percentage up to and including 14 days after collection and incubation.
Measured: ovicidal activity assessed after 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altman Biomedical Consulting Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen Barker, PhD, Principal investigator, University of Queensland, Queensland, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995124
- Sponsor's protocol ID
- KEY/NL/003
- Status last verified
- Jul 2010
- First submitted
- 13 Oct 2009
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Assessor Blind, Parallel Group, Comparative Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
- ClinicalTrials.gov ID
- NCT00995124
- Acronym / sponsor ID
- KEY/NL/003
- Conditions
- Head Lice
- Keywords
- ovicide, head lice infestation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Altman Biomedical Consulting Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Oct 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.
The purpose of this study is to compare the ovicidal activity of three head lice treatment products.
The study population will consist of Queensland primary school-aged children (Grades 1 - 7) who have at least 20 live eggs on the hair and who have not used any head lice product in the four weeks prior to the study.
Enrollment will continue to achieve 30 subjects in each treatment group (total of 90 subjects).
Detailed description
Subjects will be examined for the presence of head louse eggs. Those subjects who have at least 20 live eggs will be randomised into one of 3 treatment groups: NeutraLice Lotion, NeutraLice Advance or Moov Head Lice Solution treatment groups.
Pre-treatment: 10 eggs will be removed from the head by cutting the single hair with the live egg attached, before the treatment.
Treatment: The subject will then receive a single treatment application according to manufacturers instructions. Then the treatment will be washed from the hair as per the manufacturer's instructions.
Post-treatment: At least 10 treated (live) eggs will be removed from the head by cutting the single hair with the egg attached, after the treatment.
All of the eggs will be held in an incubator for 14 days. The proportion of eggs which hatch after 14 days will be compared for the pre-treatment and post-treatment eggs. Demographic data will be collected for each subject (hair type, hair colour, hair length, subject age, subject sex) to investigate the affect of hair type on ovicidal efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NeutraLice Lotion | Experimental | Drug: NeutraLice LotionSingle application of head lice product. |
| NeutraLice Advance | Experimental | Drug: NeutraLice Advance Solutionsingle application of head lice product |
| Moov Head Lice Solution | Active comparator | Drug: Moov Head Lice SolutionSingle application for head lice with 10 min application time. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female primary school-aged children.
- Presence of at least 20 live head lice eggs on the hair. The presence of live head lice eggs will be determined from a visual inspection of the hair.
- Parent / Guardian have given written informed consent to their child's participation in the trial.
Key exclusion criteria (4 listed)
- History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
- Treatment with any head lice product in the 4 weeks prior to participation in this trial.
- Treatment with hair dyes and bleaches within 4 weeks prior to participation in this trial.
- Presence of scalp disease(s).
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 |
|---|---|---|
| NeutraLice LotionHead lice topical application to be applied once for 10 minutes. | Drug | NeutraLice Lotion |
| NeutraLice Advance Solutionhead lice application to be applied once for 10 minutes | Drug | NeutraLice Advance |
| Moov Head Lice SolutionSingle application for head lice with 10 min application time. | Drug | Moov Head Lice Solution |
Primary outcome
Ovicidal efficacy index (OEI) The proportion of treated eggs hatched in-vitro divided by the proportion of pre-treated eggs hatched in-vitro expressed as a percentage up to and including 14 days after collection and incubation.
Time frame: ovicidal activity assessed after 14 days
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 28 Jul 2010.
Related trials for Head Lice
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
Headlice
Not yet recruiting
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.
Stephen Barker, PhD principal investigator
University of Queensland, Queensland, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NeutraLice Lotion, NeutraLice Advance Solution and Moov Head Lice Solution in people with Head Lice, run by Altman Biomedical Consulting Pty. Ltd. at 1 site in Australia.
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 3 inclusion and 4 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 28 Jul 2010. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Ovicidal efficacy index (OEI) The proportion of treated eggs hatched in-vitro divided by the proportion of pre-treated eggs hatched in-vitro expressed as a percentage up to and including 14 days after collection and incubation. (time frame: ovicidal activity assessed after 14 days). 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 28 Jul 2010.