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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22523593
Publication citations
-
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.