Condition category
Infections and Infestations
Date applied
10/10/2014
Date assigned
31/10/2014
Last edited
31/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When combing to help remove old louse eggs and nits, many people would like a comb that is more comfortable to use and does not damage hair like some of the metal combs. The plastic detection comb (PDC) is widely used for detection of louse infestation but can also remove louse eggs. This study is to find out how effective it is for removing louse eggs and nits from damp hair.

Who can participate?
Anyone over 4 years of age who has had head lice and currently has louse eggs or empty eggshells attached to the hair could take part.

What does the study involve?
Taking part in the study will usually last about 30 minutes. However, for anyone who has an active head louse infestation we can provide a treatment for that before combing the hair. The combing is performed on damp hair after hair washing and involves counting of louse eggs and nits on a selected section of hair followed by 10 strokes of the plastic comb through that section of hair to remove the eggshells. Any eggs and nits not removed will be counted after combing. The eggs and nits are removed will be collected on a tissue and then fixed into the record form for counting.

What are the possible benefits and risks of participating?
The possible benefit of the study is that participants with an infestation could get rid of their head lice without charge. The possible risks of the study is slight discomfort 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?
The study runs from the end of April 2014 until all participants have been found, which is expected to be the end of December 2014.

Who is funding the study?
KSL Consulting, Denmark.

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Burgess

ORCID ID

Contact details

Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-Cum-Quy
Cambridge
CB25 9AU
United Kingdom
+44 (0)1223 810 070
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTKL01

Study information

Scientific title

A proof of concept investigation to evaluate the effectiveness of the plastic detection comb (PDC) comb, a Class I medical device, for removal of head louse eggs and nits

Acronym

Study hypothesis

Many people would like to find a comb to help remove old louse eggs and nits that is more comfortable to use and does not damage hair like some of the metal combs. The PDC comb is widely used for detection of louse infestation but can also remove louse eggs. This trial is to find out how effective it is for removing louse eggs and nits from damp hair.

Ethics approval

West of Scotland REC 4; 17/04/2014; ref: 14/WS/0080

Study design

Observational proof of concept study form one study site

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Head louse (Peidiculus humanus capitis) infestation

Intervention

Combing with the PDC comb, which is a plastic fine-toothed comb made from Acrylonitrile butadiene styrene
(ABS) with a tooth gap of approximately 0.23 mm.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Removal of head louse eggs and nits from the hair. The measure of efficiency will be the proportion of the eggs within a delineated section of hair being removed by 10 strokes of the comb.

Secondary outcome measures

Ease of use and acceptability of the combing regimen. These will be taken during the process of the intervention, i.e. the ease of use is a subjective observation by the investigator, and the acceptability will also be assessed subjectively by simply asking the participant whether the process is comfortable or uncomfortable, so baseline will be the time point with the whole procedure completed within 10 minutes.

Overall trial start date

30/03/2014

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. People aged 4 years and over with no upper age limit
2. People who, upon examination, are confirmed to have head louse eggs and/or nits present in their hair
3. People who give written informed consent or, if the participant is under 16 years of age, whose parent/guardian gives written informed consent to participate in the study

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25 participants

Participant exclusion criteria

1. People with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition other than head lice (e.g. psoriasis of the scalp)
2. Pregnant or nursing mothers
3. People who have already participated in this clinical study

Recruitment start date

30/03/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Insect Research & Development Limited
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Organisation

KSL Consulting (Denmark)

Sponsor details

c/o Kim S Larsen
Ramløsevej 25
Helsinge
D-3200
Denmark
kim@ksl.dk

Sponsor type

Industry

Website

http://www.ksl.dk/en/

Funders

Funder type

Industry

Funder name

KSL Consulting (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes