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
Protocol serial number	CT:EP02
Sponsor	EctoPharma Ltd (UK)
Funder	EctoPharma Ltd (UK)

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

Primary study design	Interventional
Study design	Phase III, randomised, assessor-blind, multicentre, parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	1,2-octanediol at 5% (w/v) (KindaPed™), malathion 0.5% (w/v) (Derbac-M Liquid®)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	28/02/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	420
Key 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
Key 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™
Date of first enrolment	07/09/2007
Date of final enrolment	28/02/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Medical Entomology Centre

Royston
SG8 6QZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes