Condition category
Infections and Infestations
Date applied
02/06/2006
Date assigned
20/07/2006
Last edited
13/08/2012
Prospective/Retrospective
Retrospectively 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

Mrs Christine Brown

ORCID ID

Contact details

The Medical Entomology Centre
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
+44 (0)1763 263011
christine@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT:EP01

Study information

Scientific title

Acronym

KindaPed

Study hypothesis

The primary aims of this trial are to assess the efficacy and safety of KindaPed™ to eradicate head lice infection.
The secondary aims are to assess the ease of application of the product and to show the amount of lotion used for each participant and thus enable the sponsor to establish the average amount of product required for treatment.

Ethics approval

Approval by Hertfordshire Research Ethics Committee 2 (REC 2) on 25/05/2006, reference number is 06/Q0204/15

Study design

Open label, non-controlled proof of concept study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Head lice infestation

Intervention

The product will be applied directly to dry hair. Sufficient product will be applied to thoroughly moisten the hair and scalp. The product will be left in place overnight before being shampooed and rinsed off with water the next morning. The product will be reapplied at day 7(+/-1 day).

Intervention type

Drug

Phase

Phase II

Drug names

KindaPed

Primary outcome measures

1. To assess the efficacy of KindaPed™ to cure head lice infection
2. To assess the efficacy of KindaPed™ to kill head lice
3. To evaluate the efficacy of KindaPed™ to kill louse eggs
4. To monitor the safety and acceptability of KindaPed™ in clinical use

Secondary outcome measures

1. To assess the ease of application of KindaPed™
2. To assess the total treatment dose for each participant, and to calculate an average dose level for this product

Overall trial start date

08/06/2006

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged four and over
2. Patients who upon examination, are confirmed to have live head lice
3. Patients who give their written informed consent, or if the patient is less than 16 years of age, whose parent/guardian gives written informed consent to participate in the study
4. Patients who will be available for home visits from Medical Entomology Centre (MEC) study team members over the 15 days of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Patients with a known sensitivity to any of the ingredients in the product
2. Patients 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. Patients known to suffer from asthma
4. Patients who have been treated with other head lice products within the last two weeks. There must be a 14-day gap since treatment for head lice was last used before the patient can be accepted on to this trial.
5. Patients 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. Patients who have been treated with the antibiotics co-trimoxazole, septrin or trimethoprim within the last four weeks, or who are currently taking such a course
7. Pregnant or nursing mothers
8. Patients who have participated in another clinical study within one month before entry to this study
9. Patients who have already participated in this clinical study

Recruitment start date

08/06/2006

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom

Sponsor information

Organisation

EctoPharma Limited (UK)

Sponsor details

54 Queen Street
Edinburgh
EH2 3NS
United Kingdom
+44 (0)131 225 5132
magnusnicolson@aol.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

EctoPharma Limited

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