Clinical Trials Directory

Trials / Completed

CompletedNCT02974088

Neem Lotion With Combing for Lice

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Medical Entomology Centre · Industry
Sex
All
Age
6 Months
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DEVICENeem-based lotion plus louse combNeem-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 combNeem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb

Timeline

Start date
2006-05-01
Primary completion
2006-08-01
Completion
2006-08-01
First posted
2016-11-28
Last updated
2024-03-19
Results posted
2019-03-14

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02974088. Inclusion in this directory is not an endorsement.