A proof of concept clinical investigation to evaluate the activity of Hedrin® liquid gel in the treatment of head lice using a 15 minutes application time

ISRCTN ISRCTN59227204
DOI https://doi.org/10.1186/ISRCTN59227204
Secondary identifying numbers CTMK10
Submission date
04/11/2009
Registration date
02/12/2009
Last edited
18/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
We know from a previous study that Hedrin 4% gel works with a 1 hour application time. The aim of this study is to find out whether that Hedrin 4% gel works just as well to eliminate head louse infestation using just a 15 minutes application.

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 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 January 2010 and will run until about the end of May 2010.

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.

Contact information

Mr Ian Burgess
Scientific

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

Email ian@insectresearch.com

Study information

Study designSingle-centre non-randomised single-arm proof of concept study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA proof of concept clinical investigation to evaluate the activity of Hedrin® liquid gel in the treatment of head lice using a 15 minutes application time: a single-centre non-randomised single-arm proof of concept study
Study objectivesTo determine whether Hedrin® liquid gel is effective using a 15 minutes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHead louse infestation
InterventionAll participants will receive the following intervention (single-arm trial): 15 minutes application of dimeticone 4% (Hedrin® liquid gel), on day 0 (at enrolment) and day 7. Patients will be followed up for 14 days from day 0.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dimeticone (Hedrin® liquid gel)
Primary outcome measureCure 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 measures1. 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 study start date20/01/2010
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants40
Key inclusion criteria1. 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 11 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
Key exclusion criteria1. Participants with a known sensitivity to any of the ingredients in Hedrin® liquid 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
Date of first enrolment20/01/2010
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Thornton & Ross Ltd (UK)
Industry

Linthwaite
Huddersfield
HD7 5QH
United Kingdom

Email steveskilleter@thorntonross.com
Website http://www.thorntonross.com
ROR logo "ROR" https://ror.org/00frd0c49

Funders

Funder type

Industry

Thornton & Ross Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 25/01/2011 Yes No