Condition category
Infections and Infestations
Date applied
09/03/2009
Date assigned
19/03/2009
Last edited
18/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We know from previous studies that Hedrin 4% lotion gets rid of a head louse infestation. The aim of this study is to compare Hedrin 4% lotion with a modified version of the product to see if the alternative is more effective to cure head louse infestation.

Who can participate?
The study will be conducted in two schools but is open to anyone in the villages serving those schools who has head lice and is 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, 2 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 further 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 the schools of Maldan and Osmancali, two villages in Manisa province, Turkey. Our team of investigators will first visit the schools to identify students with lice and then visit them at home to run all the procedures.

When is the study starting and how long is it expected to run for?
The study was carried out in April and May of 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 Dr Özgür Kurt of Celal Bayar University School of Medicine.

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
+44 (0)1223 810070
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTMK06

Study information

Scientific title

A randomised, controlled, assessor-blind, clinical trial to compare Hedrin® 4% dimeticone lotion with Hedrin® 4% lotion Dev 42 in the treatment of head lice

Acronym

Study hypothesis

To compare efficacy of Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 in the eradication of head lice, to compare the products for ovicidal activity, and to compare the products for safety, ease of application and participant acceptability.

Ethics approval

Research Ethics Committee of the Medical Faculty, Celal Bayar University gave approval on the 25th February 2008 (ref: 25)

Study design

Randomised controlled assessor blinded parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Only available to recruiting centres/participants

Condition

Head louse infestation

Intervention

1. Dimeticone 4% lotion (Hedrin® 4% lotion)
2. Dimeticone 4% lotion, alternative mixture (Hedrin® 4% lotion Dev 42)

Both products will be applied directly to dry hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for eight hours (or overnight) before being shampooed and rinsed off with water. Treatments were applied on days 0 and 7 and post-treatment assessments were conducted on days 1, 2, 6, 9, 14.

Intervention type

Drug

Phase

Phase III

Drug names

Hedrin® 4% lotion Dev 42, Hedrin® 4% lotion

Primary outcome measures

1. To compare Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to inhibition of hatching of louse eggs (ovicidal activity): no nymphal lice emerging from eggs between treatments (i.e. on day 1, 2, or 6) or after the second treatment
2. To compare the efficacy of Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to the eradication of head lice: assessed post-second treatment, i.e. no lice on days 9 or 14

Secondary outcome measures

To compare Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to safety, ease of application and participant acceptability, assessments made on days 0 and 7 post-treatment application and at each of the efficacy assessments on days 1, 2, 6, 9, and 14

Overall trial start date

01/04/2008

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 4 years 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

68

Participant exclusion criteria

1. Participants with a known sensitivity to any of the ingredients in Hedrin® 4% lotion or Hedrin® 4% lotion Dev 42
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

01/04/2008

Recruitment end date

31/05/2008

Locations

Countries of recruitment

Turkey

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

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

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