Condition category
Infections and Infestations
Date applied
07/04/2008
Date assigned
29/05/2008
Last edited
26/11/2009
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
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
+44 1763 263011
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTOM01, version 1.3 (18/02/2008)

Study information

Scientific title

A randomised, controlled, assessor-blind, clinical trial to investigate superiority of Lyclear® spray away (ParaNix® spray) compared with Infectopedicul® permethrin 0.5% lotion in the treatment of head lice

Acronym

Study hypothesis

To investigate superiority of Lyclear® spray away (ParaNix® spray) over Infectopedicul® in the eradication of head lice and prevention of hatching of louse eggs and to compare the products for safety, ease of application and participant acceptability.

Ethics approval

Leeds (West) Research Ethics Committee. Date of approval: 04/03/2008 (ref: 08/H1307/18)

Study design

Randomised, controlled, assessor blind, parallel group study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infestation with head lice (Pediculus capitis)

Intervention

The participants will be randomly allocated to the two groups in equal numbers.

Group 1: Participants will be treated with Lyclear® spray away (ParaNix® spray; topical) containing:
Active: Illicium verum (star anise) oil, caprylic/capric triglyceride (fractionated coconut oil derivative), cananga odorata (ylang-ylang) oil
Excipients: Propan-2-ol

Group 2: Participants will be treated with Infectopedicul® lotion (topical) containing:
Active: 0.5% permethrin
Excipients: Ethanol, propanol-2-ol, water, propylene glycol, sodium hydrogen phosphate

The total duration of intervention and follow-up for each participant is 15 days, two treatments 9 days apart with a follow-up 2 and 7 days after the first treatment and 2 and 5 days after the second treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

Permethrin

Primary outcome measures

1. Number of participants with no evidence of active head louse infestation 14 days (+/- 1 day) after enrolment
2. Safety, assessed 2 and 7 days after the first treatment, and 2 and 5 days after the second treatment

Secondary outcome measures

1. Ease of application (investigator opinion), assessed using a questionnaire on the same day as the first treatment
2. Participant acceptability, assessed using a questionnaire 5 days after the second treatment

Overall trial start date

23/03/2008

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 2 years and over with no upper age limit
2. Participants who upon examination, are confirmed to have live head lice
3. Participants 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. Participants who will be available for home visits by Medical Entomology Centre (MEC) study team members over the 14 days following first treatment

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Participants with a known sensitivity to any of the ingredients in Lyclear® spray away (ParaNix® spray) or Infectopedicul® lotion
2. Participants with asthma or a similar respiratory condition
3. Participants 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)
4. Participants who have been treated with other head lice products within the previous two weeks
5. Participants who have bleached hair, or hair that has been colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable)
6. Participants who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
7. Pregnant or nursing mothers
8. Participants who have participated in another clinical study within 1 month before entry to this study
9. Participants who have already participated in this clinical study

Recruitment start date

23/03/2008

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom

Sponsor information

Organisation

Omega Pharma N.V. (Belgium)

Sponsor details

Venecoweg 26
Nazareth
B-9810
Belgium

Sponsor type

Industry

Website

http://www.omega-pharma.be

Funders

Funder type

Industry

Funder name

Omega Pharma N.V. (Belgium)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19343362

Publication citations

  1. Results

    Burgess IF, Brunton ER, Burgess NA, Clinical trial showing superiority of a coconut and anise spray over permethrin 0.43% lotion for head louse infestation, ISRCTN96469780., Eur. J. Pediatr., 2010, 169, 1, 55-62, doi: 10.1007/s00431-009-0978-0.

Additional files

Editorial Notes