PediculosesPhase 2NCT02974088
Neem Lotion With Combing for Lice
A Phase 2 study testing Neem-based lotion plus louse comb and Neem-based lotion plus grooming comb in people with Pediculoses and Head Lice, run by Medical Entomology Centre at 1 site in United Kingdom.
Trial summary
This was a Phase IIa randomised, assessor blinded, parallel group study in which half the participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with a head louse detection and removal comb and the remainder were treated with Nice 'n Clear plus combing with a normal grooming comb Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculoses, Head Lice
- What is being tested?
- Neem-based lotion plus louse comb and Neem-based lotion plus grooming comb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2006to Aug 2006
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males and females who are found to have an active head louse infection, i.e. the presence of live lice. Detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found.
- People who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. Assent/verbal assent forms will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit.
- Participants must be available for the duration of the study i.e. 15 days.
Who cannot join
- People who have been treated with other head louse products within the previous 2 weeks (14 days).
- People who have undergone a course of antibiotic treatment using Cotrimoxazole, Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such a course.
- People whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home use wash in/wash out colouring agents are acceptable.
- People who have taken part in another clinical study within 4 weeks prior to entry to this one.
- Females who are pregnant or breast-feeding.
- Participants who have already taken part in this study.
- People who have a known allergy to any of the ingredients of Nice 'n Clear Lotion (including allergy to Paraben preservatives)
- Children under 6 months of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Assessor Blinded "Proof of Concept" (Phase IIa) Clinical Study to Assess the Efficacy and Safety of Nice 'n Clear Head Lice Lotion in the Treatment of Head Lice
This was a Phase IIa randomised, assessor blinded, parallel group study in which half the participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with a head louse detection and removal comb and the remainder were treated with Nice 'n Clear plus combing with a normal grooming comb
Read the detailed description
Neem oil has had a long reputation for killing a wide range of insects, including head lice. Several products are marketed with this oil as a named active ingredient, e.g. Nice 'n Clear neem-based conditioning lotion. This product was developed as an aid to combing out head lice for eliminating infestation but it has been considered possible that the neem oil could act to kill lice and inhibit their eggs from hatching.
This study was designed to compare use of Nice 'n Clear neem-based conditioning lotion when used with two different types of comb. One arm of the study was planned so that participants were combed using a plastic louse detection and removal comb (wet combing with conditioner method), in which it was expected the combing process would play a major role in efficacy. The other arm was planned so that participants were combed using a regular grooming comb, which would normally have little effect for removing head lice from the hair.
Comparison of the efficacy outcome in the two groups would determine whether the Nice 'n Clear neem-based conditioning lotion exhibited any effect to eliminate infestation independent of the combing
- Conditions
- Pediculoses, Head Lice
- Being tested
- Neem-based lotion plus louse comb, Neem-based lotion plus grooming comb
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neem-based lotion plus louse combDevice
Also called Nice 'n Clear
Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb
Neem-based lotion plus grooming combDevice
Also called Nice 'n Clear
Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
| Study group | Role | What they receive |
|---|---|---|
| Neem-based lotion plus louse comb | Experimental | Neem-based conditioning lotion plus head louse detection and removal comb Receives: Device: Neem-based lotion plus louse comb |
| Neem-based lotion plus grooming comb | Experimental | Neem-based conditioning lotion plus regular grooming comb Receives: Device: Neem-based lotion plus grooming comb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing
Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10
Measured: 15 days
Secondary outcomes (2)
Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used
It was expected that the louse comb group would show a high level of success (elimination of infestation). The measure of efficacy of the neem-based lotion was the relative efficacy observed in the grooming comb group compared with the louse comb group
Measured: 15 days
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Number of participants with application site reactions such as irritation, erythema, or other events related to treatment
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startMay 2006
- Primary completionAug 2006
- Study completionAug 2006
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.
- Other trials for PediculosesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Entomology Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leeds Health Protection Unit, PN Lee Statistics and Computing Ltd, Nelsons
- Responsible party
- Principal investigator, Ian F Burgess, Medical Entomology Centre
- Investigators
- Ian F Burgess, Principal investigator, Medical Entomology Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974088
- Sponsor's protocol ID
- CTNC01
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2016
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Contact Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Assessor Blinded "Proof of Concept" (Phase IIa) Clinical Study to Assess the Efficacy and Safety of Nice 'n Clear Head Lice Lotion in the Treatment of Head Lice
- ClinicalTrials.gov ID
- NCT02974088
- Acronym / sponsor ID
- CTNC01
- Conditions
- Pediculoses, Head Lice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medical Entomology CentreIndustry (pharma, biotech, devices)
- Collaborators
- Leeds Health Protection Unit, PN Lee Statistics and Computing Ltd, Nelsons
- Study start
- May 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase IIa randomised, assessor blinded, parallel group study in which half the participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with a head louse detection and removal comb and the remainder were treated with Nice 'n Clear plus combing with a normal grooming comb
Detailed description
Neem oil has had a long reputation for killing a wide range of insects, including head lice. Several products are marketed with this oil as a named active ingredient, e.g. Nice 'n Clear neem-based conditioning lotion. This product was developed as an aid to combing out head lice for eliminating infestation but it has been considered possible that the neem oil could act to kill lice and inhibit their eggs from hatching.
This study was designed to compare use of Nice 'n Clear neem-based conditioning lotion when used with two different types of comb. One arm of the study was planned so that participants were combed using a plastic louse detection and removal comb (wet combing with conditioner method), in which it was expected the combing process would play a major role in efficacy. The other arm was planned so that participants were combed using a regular grooming comb, which would normally have little effect for removing head lice from the hair.
Comparison of the efficacy outcome in the two groups would determine whether the Nice 'n Clear neem-based conditioning lotion exhibited any effect to eliminate infestation independent of the combing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neem-based lotion plus louse comb | Experimental | Device: Neem-based lotion plus louse combNeem-based conditioning lotion plus head louse detection and removal comb |
| Neem-based lotion plus grooming comb | Experimental | Device: Neem-based lotion plus grooming combNeem-based conditioning lotion plus regular grooming comb |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females who are found to have an active head louse infection, i.e. the presence of live lice. Detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found.
- People who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. Assent/verbal assent forms will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit.
- Participants must be available for the duration of the study i.e. 15 days.
Key exclusion criteria (8 listed)
- People who have been treated with other head louse products within the previous 2 weeks (14 days).
- People who have undergone a course of antibiotic treatment using Cotrimoxazole, Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such a course.
- People whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home use wash in/wash out colouring agents are acceptable.
- People who have taken part in another clinical study within 4 weeks prior to entry to this one.
- Females who are pregnant or breast-feeding.
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 |
|---|---|---|
| Neem-based lotion plus louse combAlso: Nice 'n ClearNeem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb | Device | Neem-based lotion plus louse comb |
| Neem-based lotion plus grooming combAlso: Nice 'n ClearNeem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb | Device | Neem-based lotion plus grooming comb |
Primary outcome
Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing
Time frame: 15 days
Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10
2 secondary outcomes
Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used
Time frame: 15 days
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Final Report Summary - ClearBrush (A Novel Integrated Ultrasonic Brush and Sonically Activated Lotion to Provide a Full System Approach to the Eradication of the European Head Louse Menace)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Contact Principal Investigator
Related trials for Pediculoses
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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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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.
Ian F Burgess principal investigator
Medical Entomology Centre
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 Neem-based lotion plus louse comb and Neem-based lotion plus grooming comb in people with Pediculoses and Head Lice, run by Medical Entomology Centre at 1 site in United Kingdom.
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 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 19 Mar 2024. 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 Kingdom. 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 14 Mar 2019). 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 From Head Louse Infestation as Assessed by Detection Combing (time frame: 15 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 19 Mar 2024.