Plain English Summary
Background and study aims
We know from previous studies that Hedrin 4% lotion is effective with an 8 hour application time and reasonably effective with a 20 minutes application. The aim of this study is to confirm that Hedrin 4% lotion works just as well to eliminate head louse infestation using it for 1 hour.
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 8 hours application) 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 dont need to go anywhere.
When is the study starting and how long is it expected to run for?
The study starts in November 2008 and will run until about the end of February 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
http://orcid.org/0000-0003-0747-3938
Contact details
Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
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ian@insectresearch.com
Additional identifiers
EudraCT number
2008-005787-13
ClinicalTrials.gov number
Protocol/serial number
CTMK08
Study information
Scientific title
A proof of concept clinical investigation to evaluate the activity of Hedrin® 4% lotion in the treatment of head lice using a 1-hour application time
Acronym
Study hypothesis
To determine whether Hedrin® 4% lotion can be used for a shorter application time (1 hour) in the eradication of head lice than the currently approved overnight application, and to evaluate the treatment regimen with regard to safety, ease of application, and participant acceptability.
Ethics approval
Essex 1 Research Ethics Committee, approved on 27/10/2008 (ref: 08/H0301/114)
Study design
Single-centre non-randomised single-arm proof of concept study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
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%) lotion, on day zero (at enrolment) and day 7.
Intervention type
Drug
Phase
Phase IV
Drug names
Dimeticone (Hedrin®)
Primary outcome measure
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
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. Participant acceptability, assessed by a questionnaire at the final assessment on day 14
Overall trial start date
17/11/2008
Overall trial end date
31/01/2009
Reason abandoned (if study stopped)
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% lotion
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
17/11/2008
Recruitment end date
31/01/2009
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
Sponsor type
Industry
Website
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
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list