Condition category
Infections and Infestations
Date applied
07/11/2007
Date assigned
05/02/2008
Last edited
18/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Head lice are tiny insects that live in hair. Nits are the empty egg cases attached to hair that head lice hatch from. There are several different products (insecticides) that can be applied to the scalp and hair to kill head lice. Some head louse treatments are not effective because they are difficult to use or the lice are resistant to the insecticide. The original formula Nice ‘n Clear head lice lotion (ONC) was conditioner-based and not effective to eliminate lice but it was good as a combing aid. This study tests a lotion containing neem oil, believed to be an active material to coat the lice (new formula Nice ‘n Clear), and compares it with an isopropyl myristate and silicone-based product (Full Marks solution). The study also looks at a new way to remove louse eggs and nits using an ultrasound comb (Clearbrush). The effectiveness of the comb is assessed using new formula Nice ‘n Clear in comparison with original Nice ‘n Clear.

Who can participate?
Anyone over 4 years of age who has head lice

What does the study involve?
Participants are randomly allocated to receive one of four treatments: new formula Nice ‘n Clear, Full Marks solution, Clearbrush and new formula Nice ‘n Clear, or Clearbrush and original formula Nice ‘n Clear. All treatments are applied on the first day, with repeat treatment after 7 days, and there are four follow-ups over 2 weeks to see how well they work.

What are the possible benefits and risks of participating?
The possible benefit of the study is that patients could get rid of their head lice without charge. The possible risks of the study are discomfort or irritation where the treatment is applied either during or after the treatment, or pulling of the hair during combing.

Where is the study run from?
Medical Entomology Centre, Insect Research & Development Limited (UK)

When is the study starting and how long is it expected to run for?
September to December 2007

Who is funding the study?
Sixth Framework Programme

Who is the main contact?
Mr Ian Burgess
ian@insectresearch.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Burgess

ORCID ID

http://orcid.org/0000-0003-0747-3938

Contact details

Medical Entomology Centre
Insect Research & Development Limited
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
+44 (0)1763 263011
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol CTNC02, Version: 1.0, 20 February 2007

Study information

Scientific title

A randomised, assessor-blinded clinical study to compare the efficacy and safety of Nice 'n Clear with Full Marks solution and to evaluate a novel ultrasound comb device 'ClearBrush' for removal of nits

Acronym

ClearBrush

Study hypothesis

This study has two elements; in the first a comparison will be made of the silicone-based Nice 'n Clear with that of Full Marks solution. At the same time ClearBrush will be evaluated for efficacy at removing louse eggs and nits using both the new formulation of Nice 'n Clear and the original formulation.

The data obtained from the comparison of Nice 'n Clear with Full Marks solution and the data obtained in the earlier CTNC01 study will be used as baseline data for comparing the efficacy of ClearBrush to facilitate louse egg removal using each of these lubricants. Safety, ease of application, and participant acceptability of each of the products will also be assessed.

Ethics approval

Cambridgeshire 1 Research Ethics Committee, 20/06/2007, ref: 07/Q0104/44

Study design

Randomised single-blind (assessor-blind) parallel-group comparative multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Head louse infestation (pediculosis capitis)

Intervention

1. Herbal-based (neem oil, with tea tree, thyme and lemongrass essential oils) lotion in a silicone vehicle (reformulated Nice 'n Clear lotion) (66 participants)
2. Isopropyl myristate/cyclomethicone lotion (Full Marks solution) (66 participants)
3. ClearBrush ultrasound nit-removing comb in combination with herbal-based lotion in an aqueous cream vehicle (original Nice 'n Clear head louse treatment lotion) (22 participants)
4. ClearBrush ultrasound nit-removing comb in combination with herbal-based lotion in a silicone vehicle (reformulated Nice 'n Clear lotion) (22 participants)

The total time for intervention and follow-up for each participant is 15 days, two treatments a week apart with a follow-up 2 and 6 days after the first treatment and 2 and 7 days after the second treatment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Efficacy of using reformulated Nice 'n Clear lotion in comparison with Full Marks solution to cure an infection, i.e. no lice at the days 9 and 14 assessments
2. Efficacy of the ClearBrush in use with the new and the original Nice 'n Clear head lice treatment preparations, measured using data obtained from each treatment, i.e. on days 7 and 14

Secondary outcome measures

Safety and acceptability of the Nice ‘n Clear preparations and Full Marks solution, measured at the end of the 15 days

Overall trial start date

13/09/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female participants 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. Any lice found at these assessments will not be removed
2. Participants 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. An assent form will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit. The lower age limit for this study will be 2 years (Nice 'n Clear is marketed as a medical device for babies and children down to the age of 6 months and Full Marks solution for children down to 2 years)
3. Participants must be available for the duration of the study, i.e. 15 days

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

176

Participant exclusion criteria

1. Participants who have been treated with other head louse products within the previous 2 weeks (14 days)
2. Participants 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
3. Participants 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.
4. Participants who have taken part in another clinical study within 4 weeks prior to entry to this one
5. Female participants who are pregnant or breastfeeding
6. Participants who have already taken part in this study
7. Participants who have a known allergy to any of the ingredients of either of the Nice 'n Clear preparations or Full Marks solution (including allergy to Paraben preservatives)
8. Children under 2 years of age

Recruitment start date

13/09/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Insect Research & Development Limited
Royston
SG8 6QZ
United Kingdom

Sponsor information

Organisation

Nelsons (UK)

Sponsor details

Nelsons House
83 Parkside
Wimbledon
London
SW19 5LP
United Kingdom

Sponsor type

Industry

Website

http://www.nelsons.net/corporate_home

Funders

Funder type

Government

Funder name

Sixth Framework Programme (contract number: 017916-ClearBrush)

Alternative name(s)

EC Sixth Framework Programme, European Commission Sixth Framework Programme, EU Sixth Framework Programme, European Union Sixth Framework Programme, EU 6th Framework Programme, European Union 6th Framework Programme, FP6

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Results and Publications

Publication and dissemination plan

The manuscript describing the study is currently in press.

IPD sharing statement
The datasets generated during and/or analysed during the current study are available upon request from Mr Ian Burgess (ian@insectresearch.com).

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/05/2017: Plain English summary added.