Condition category
Infections and Infestations
Date applied
09/02/2009
Date assigned
13/03/2009
Last edited
17/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
We know from a previous study that Hedrin 4% lotion is effective with a 1 hour application time. The aim of this study is to confirm that Hedrin 4% gel, a more viscous version of the product that should be easier to use, works just as well to eliminate head louse infestation.

Who can participate?
The study is open to anyone who has head lice over the age of 6 months and who fits the other entry criteria.

What does the study involve?
The study first involves checking for presence of lice. If you then wish to take part we shall ask you (or your carer) to sign a consent form after which we can apply the treatment. A second application of the treatment product is applied after 7 days to eliminate any young lice that emerge from eggs during that first week. We shall check the safety and acceptability of the treatment and the progress of the effectiveness when we comb everyone looking for lice twice between treatments, on days 1 and 6 after first treatment, and then twice after the second treatment on days 9 and 14. Anyone who has lice after the second treatment will be provided with a different treatment (Hedrin 4% lotion) to eliminate the infestation.

What are the possible benefits and risks of participating?
We hope everyone who takes part will have their head lice eliminated.

Where is the study run from?
The study will be conducted in and around the area of Cambridgeshire by the Medical Entomology Centre based just outside Cambridge. Our team of investigators will visit you at home to run all the procedures so you don’t need to go anywhere.

When is the study starting and how long is it expected to run for?
The study starts in April or May 2009 and will run until about the end of July 2009.

Who is funding the study?
It is being funded by Thornton & Ross Ltd, the makers of Hedrin 4% lotion.

Who is the main contact?
The main contact for the study is Elizabeth Brunton at the Medical Entomology Centre.

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Burgess

ORCID ID

Contact details

Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
-
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTMK09

Study information

Scientific title

A proof of concept clinical investigation to evaluate the activity of Hedrin® 4% gel in the treatment of head lice using a 1-hour application time: a single-centre non-randomised single-arm proof of concept study

Acronym

Study hypothesis

To determine whether Hedrin® 4% gel is effective using a 1-hour application in the eradication of head lice, and to evaluate the treatment regimen with regard to safety, ease of application, ease of washing, and participant acceptability.

Ethics approval

South West Research Ethics Committee, 03/04/2009, ref: 09/H0206/16

Study design

Single-centre non-randomised single-arm proof of concept study

Primary study design

Interventional

Secondary study design

Non randomised study

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 infestation

Intervention

All participants will received the following intervention (single-arm trial):
One-hour application of dimeticone 4% (Hedrin® 4%) gel, on day zero (at enrolment) and day 7.

Intervention type

Drug

Phase

Not Specified

Drug names

Hedrin® 4% gel

Primary outcome measures

Cure of infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment being applied on day 0).

Secondary outcome measures

1. Prevention of louse egg hatching (ovicidal action), defined as no 1st and 2nd stage nymphs found at assessments during the week following the first treatment or after the second application of treatment
2. Safety of the product monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study
3. Ease of use by investigators, assessed by a questionnaire on the day of the first treatment
4. Ease of washing from the hair, assessed by a participant questionnaire at the final assessment on day 14
5. Participant acceptability, assessed by a questionnaire at the final assessment on day 14

Overall trial start date

20/04/2009

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 6 months and over with no upper age limit
2. Participants who upon examination, are confirmed to have live head lice
3. Participants 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
4. Participants who will be available for follow-up visits by study team members over the 14 days following first treatment

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Participants with a known sensitivity to any of the ingredients in Hedrin® 4% gel
2. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition (e.g. psoriasis of the scalp)
3. Participants who have been treated with other head lice products within the previous two weeks
4. Participants who have bleached hair, or hair that has been permanently waved within the previous four weeks
5. Participants who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
6. Pregnant or nursing mothers
7. Participants who have participated in another clinical study within 1 month before entry to this study
8. Participants who have already participated in this clinical study

Recruitment start date

20/04/2009

Recruitment end date

01/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Organisation

Thornton & Ross Ltd (UK)

Sponsor details

Linthwaite
Huddersfield
HD7 5QH
United Kingdom
-
steveskilleter@thorntonross.com

Sponsor type

Industry

Website

http://www.thorntonross.com

Funders

Funder type

Industry

Funder name

Thornton & Ross Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

17/08/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/08/2016: Study status verified with principal investigator. Ethics approval information added. 20/07/2016: No publications found, verifying study status with principal investigator