Neem Lotion With Combing for Lice

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

NCT00963508

Pediculosis

COMPLETED PHASE3

Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

NCT00927472

Pediculosis

COMPLETED PHASE3

A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infestation

NCT05565820

Pediculosis Capitis Lice Infestations Head Lice

COMPLETED PHASE4

Effectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs

NCT02569580

Lice

UNKNOWN NA

Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice

NCT00479310

Head Lice

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pediculoses Head Lice

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neem-based lotion plus louse comb

Neem-based conditioning lotion plus head louse detection and removal comb

Group Type EXPERIMENTAL

Neem-based lotion plus louse comb

Intervention Type DEVICE

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 plus regular grooming comb

Group Type EXPERIMENTAL

Neem-based lotion plus grooming comb

Intervention Type DEVICE

Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nice 'n Clear Nice 'n Clear

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes