Neem Lotion With Combing for Lice

Head Lice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974088
• Other study ID #: CTNC01
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: March 2024
• Source: Medical Entomology Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Head Lice
• Lice Infestations
• Pediculoses

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	Medical Entomology Centre	Cambridge

Sponsors (4)

Lead Sponsor	Collaborator
Medical Entomology Centre	Leeds Health Protection Unit, Nelsons, PN Lee Statistics and Computing Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	15 days
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	15 days
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	15 days

External Links

•   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)