Condition category
Infections and Infestations
Date applied
09/05/2007
Date assigned
22/05/2007
Last edited
13/08/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Burgess

ORCID ID

Contact details

Medical Entomology Centre
Insect Research and Development Ltd
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT:EP02

Study information

Scientific title

Acronym

Study hypothesis

To compare the efficacy of each of two different application regimens (two-hour and eight-hour) of KindaPed™ with the standard regimen of Derbac-M Liquid® in eliminating infestation (achieving cure or re-infestation) following two treatment applications.

Ethics approval

Ethics approval received from the Trent Research Ethics Committee on the 13th July 2007 (ref: 07/MRE04/39).

Study design

Phase III, randomised, assessor-blind, multicentre, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Treatment of head louse infection

Intervention

The participants hair will be combed with a fine toothed comb at the start of the study and on a further five occasions in order to assess the level of head lice infection. The study treatment will be applied on the treatment days (two days one week apart).

Intervention (1,2-octanediol at 5% [w/v] [KindaPed™]):
Dosage will be one bottle (100 ml) applied for either two hours or for eight hours to dry hair. Enough product will be used to soak the hair. A second bottle may be used if the hair is long and/or thick. The hair will be left to dry naturally and washed the following morning with normal shampoo and dried in the normal fashion. The product is applied on Day 0 of the trial and again on Day 7 (± 1 day). The subjects will be followed up until their final visit on Day 14. Any adverse events will be followed until resolution or stabilisation.

Comparator (malathion 0.5% [w/v] [Derbac-M Liquid®]):
Dosage will be one bottle (200 ml) applied for eight hours to dry hair. Enough product will be used to soak the hair. The hair will be left to dry naturally and washed the following morning with normal shampoo and dried in the normal fashion. The product is applied on Day 0 of the trial and again on Day 7 (± 1 day). The subjects will be followed up until their final visit on Day 14. Any adverse events will be followed until resolution or stabilisation.

Intervention type

Drug

Phase

Phase III

Drug names

1,2-octanediol at 5% (w/v) (KindaPed™), malathion 0.5% (w/v) (Derbac-M Liquid®)

Primary outcome measures

The primary endpoint is the proportion of subjects satisfying the criteria for cure or re-infestation as defined by the treatment outcome algorithm. These subjects will all have been cured of the infestation evident at Day 0.

Secondary outcome measures

Secondary measures will be:
1. The proportion of subjects satisfying the criteria for cure based only on the assessments at Days 2and 6 following the first treatment application
2. The proportion of subjects satisfying the criteria for killing lice following two treatment applications
3. The proportion of subjects satisfying the criteria for killing eggs following two treatment applications
4. The safety of the study products, as determined by the occurrence of adverse events
5. Ease of application of the study products as assessed by an investigator questionnaire
6. Subject assessment of acceptability

Overall trial start date

07/09/2007

Overall trial end date

28/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects aged four and over
2. Subjects who upon examination are confirmed to have live head lice
3. Subjects who have given written informed consent, or, if the subject is less than 16 years of age, whose parent/guardian has given written informed consent to participate in the study
4. Subjects who will be available for home visits from research staff over the 15 days of the study

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

420

Participant exclusion criteria

1. Subjects with a known sensitivity to any of the ingredients in the products
2. Subjects with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a long-term scalp condition (e.g. psoriasis of the scalp)
3. Subjects currently on prescribed medication for the prophylaxis or treatment of asthma (‘currently’ will be interpreted as meaning that the subject has used asthma medication within the previous four months)
4. Subjects who have been treated with other head lice products within the last two weeks. There must have been a 14-day gap since treatment for head lice was last used before the subject can be accepted into this trial
5. Subjects who have bleached hair, or hair that has been colour treated or permanently waved within the last four weeks (wash in/wash out colours are acceptable)
6. Subjects who have been treated with the antibiotics Co-Trimoxazole, Septrin or Trimethoprim within the previous four weeks, or who are currently taking such a course
7. Pregnant or nursing mothers
8. Subjects who have participated in another clinical trial within one month prior to entry to this study
9. Subjects who have already participated in this clinical study or any clinical study of KindaPed™

Recruitment start date

07/09/2007

Recruitment end date

28/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom

Sponsor information

Organisation

EctoPharma Ltd (UK)

Sponsor details

54 Queen Street
Edinburgh
EH2 3NS
United Kingdom

Sponsor type

Industry

Website

http://www.ectopharma.com

Funders

Funder type

Industry

Funder name

EctoPharma 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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22523593

Publication citations

  1. Results

    Burgess IF, Lee PN, Kay K, Jones R, Brunton ER, 1,2-Octanediol, a novel surfactant, for treating head louse infestation: identification of activity, formulation, and randomised, controlled trials., PLoS ONE, 2012, 7, 4, e35419, doi: 10.1371/journal.pone.0035419.

Additional files

Editorial Notes