Head Lice, Pediculoses
Conditions
Brief 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
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
Interventions
DEVICENeem-based lotion plus louse comb
Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb
DEVICENeem-based lotion plus grooming comb
Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Sponsors
Leeds Health Protection Unit
PN Lee Statistics and Computing Ltd
Nelsons
Medical Entomology Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing | 15 days | Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used | 15 days | 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 |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 15 days | Number of participants with application site reactions such as irritation, erythema, or other events related to treatment |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment between 26 May 2006 and 31 August 2006. Community recruitment with domiciliary visits
Pre-assignment details
None defined
Participants by arm
| Arm | Count |
|---|---|
| Neem-based Lotion Plus Louse Comb Neem-based conditioning lotion plus head louse detection and removal comb
Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb | 23 |
| Neem-based Lotion Plus Grooming Comb Neem-based conditioning lotion plus regular grooming comb
Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Neem-based Lotion Plus Grooming Comb | Total | Neem-based Lotion Plus Louse Comb |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 39 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 8 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 22 participants | 45 participants | 23 participants |
| Sex: Female, Male Female | 22 Participants | 41 Participants | 19 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 1 / 23 | 1 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
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
Time frame: 15 days
Population: All participants who completed the 15 study days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neem-based Lotion Plus Louse Comb | Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing | 23 Participants |
| Neem-based Lotion Plus Grooming Comb | Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing | 22 Participants |
Secondary
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
Time frame: 15 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neem-based Lotion Plus Louse Comb | Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used | 23 Participants |
| Neem-based Lotion Plus Grooming Comb | Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used | 22 Participants |
Secondary
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
Time frame: 15 days