A multicentre phase III trial of 1,2-octanediol at 5% (w/v) (KindaPed™) compared with malathion 0.5% (w/v) (Derbac-M Liquid®) in the treatment of head lice

ISRCTN ISRCTN91870666
DOI https://doi.org/10.1186/ISRCTN91870666
Secondary identifying numbers CT:EP02
Submission date
09/05/2007
Registration date
22/05/2007
Last edited
13/08/2012
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

Not provided at time of registration

Contact information

Mr Ian Burgess
Scientific

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

Study information

Study designPhase III, randomised, assessor-blind, multicentre, parallel group trial
Primary study designInterventional
Secondary study designRandomised 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 title
Study objectivesTo 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(s)Ethics approval received from the Trent Research Ethics Committee on the 13th July 2007 (ref: 07/MRE04/39).
Health condition(s) or problem(s) studiedTreatment of head louse infection
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)1,2-octanediol at 5% (w/v) (KindaPed™), malathion 0.5% (w/v) (Derbac-M Liquid®)
Primary outcome measureThe 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 measuresSecondary 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 study start date07/09/2007
Completion date28/02/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants420
Key inclusion criteria1. 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
Key exclusion criteria1. 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™
Date of first enrolment07/09/2007
Date of final enrolment28/02/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom

Sponsor information

EctoPharma Ltd (UK)
Industry

54 Queen Street
Edinburgh
EH2 3NS
United Kingdom

Website http://www.ectopharma.com

Funders

Funder type

Industry

EctoPharma 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 01/07/2012 Yes No