Condition category
Infections and Infestations
Date applied
27/09/2010
Date assigned
11/10/2010
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

Mr Ian Burgess

ORCID ID

Contact details

Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
+44 (0)1223 810 070
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTMK12

Study information

Scientific title

A randomised, assessor blinded, clinical trial to confirm the efficacy of a CE marked class I medical device formulation in the treatment of head lice

Acronym

Study hypothesis

A randomised, assessor blind clinical investigation designed to confirm efficacy in use and obtain further information about routine usage of two variants of the same CE marked class I medical device product based on 1,2-octanediol in the control and elimination of head louse infestation.

Ethics approval

Leeds (West) Research Ethics Committee approved (provisionally) on the 20th September 2010 (ref: 10/H1307/106)

Study design

Two-centre randomised three-arm comparative study

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

Head louse infestation

Intervention

Group A: KindaPed AF (5% 1,2-octanediol alcohol free lotion), applied for 2 hours (maximum 2.5 hours) before washing off using shampoo, with a repeat treatment one week later.

Group B: KindaPed AF (5% 1,2-octanediol alcohol free lotion), applied for 8 hours (minimum) or overnight before washing off using shampoo, with a repeat treatment one week later.

Group C: KindaPed lotion (5% 1,2-octanediol lotion with 20% alcohol), applied for 2 hours (maximum 2.5 hours) before washing off using shampoo, with a repeat treatment one week later.

Intervention type

Other

Phase

Phase II/III

Drug names

Primary outcome measures

Cure of infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment being applied on day 0).

Secondary outcome measures

1. Prevention of louse egg hatching (ovicidal action), defined as no 1st and 2nd stage nymphs found at assessments during the week following the first treatment or after the second application of treatment
2. Safety of the product monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study
3. Ease of use by investigators, assessed by a questionnaire on the day of the first treatment
4. Participant acceptability, assessed by a questionnaire at the final assessment on day 14

Overall trial start date

10/10/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 6 months and over with no upper age limit
2. People who upon examination, are confirmed to have live head lice
3. People who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study
4. People who will be available for follow-up visits by study team members over the 14 days following first treatment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120 divided into three groups of 40

Participant exclusion criteria

1. People with a known sensitivity to any of the ingredients in KindaPed AF (5% 1,2-octanediol alcohol free lotion) or in KindaPed lotion (5% 1,2-octanediol lotion with 20% alcohol)
2. People with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition (e.g. psoriasis of the scalp)
3. People who have been treated with other head lice products within the previous two weeks
4. People who have bleached hair, or hair that has been permanently waved within the previous four weeks
5. People who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
6. Pregnant or nursing mothers
7. People who have participated in another clinical study within 1 month before entry to this study
8. People who have already participated in this clinical study

Recruitment start date

10/10/2010

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Organisation

Thornton & Ross Ltd (UK)

Sponsor details

c/o Steve Skilleter
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
+44 (0)1484 842 217
steveskilleter@thorntonross.com

Sponsor type

Industry

Website

http://www.thorntonross.com

Funders

Funder type

Industry

Funder name

Thornton & Ross 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