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Neem Lotion With Combing for Lice

Primary Purpose

Pediculoses, Head Lice

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Neem-based lotion plus louse comb

Neem-based lotion plus grooming comb

About this trial

This is an interventional treatment trial for Pediculoses

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Medical Entomology Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Neem-based lotion plus louse comb

Neem-based lotion plus grooming comb

Arm Description

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

Neem-based conditioning lotion plus regular grooming comb

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Number of participants with application site reactions

Full Information

NCT ID

NCT02974088

First Posted

November 21, 2016

Last Updated

November 16, 2018

Sponsor

Medical Entomology Centre

Collaborators

Leeds Health Protection Unit, PN Lee Statistics and Computing Ltd, Nelsons

1. Study Identification

Unique Protocol Identification Number

NCT02974088

Brief Title

Neem Lotion With Combing for Lice

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical Entomology Centre

Collaborators

Leeds Health Protection Unit, PN Lee Statistics and Computing Ltd, Nelsons

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediculoses, Head Lice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neem-based lotion plus louse comb

Arm Type

Experimental

Arm Description

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

Arm Title

Neem-based lotion plus grooming comb

Arm Type

Experimental

Arm Description

Neem-based conditioning lotion plus regular grooming comb

Intervention Type

Device

Intervention Name(s)

Neem-based lotion plus louse comb

Other Intervention Name(s)

Nice 'n Clear

Intervention Description

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

Intervention Name(s)

Neem-based lotion plus grooming comb

Other Intervention Name(s)

Nice 'n Clear

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing

Description

Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used

Description

Time Frame

15 days

Title

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Description

Number of participants with application site reactions

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian F Burgess

Organizational Affiliation

Medical Entomology Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Entomology Centre

City

Cambridge

ZIP/Postal Code

CB25 9AU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Contact Principal Investigator

Links:

URL

http://cordis.europa.eu/result/rcn/46970_en.html

Description

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)

Learn more about this trial

Neem Lotion With Combing for Lice

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