Condition category
Infections and Infestations
Date applied
04/07/2013
Date assigned
30/07/2013
Last edited
26/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Some head louse treatments are not effective because they are difficult to use. This trial looked at a mousse containing phenothrin, an insecticide that is used in other products for killing head lice. We think that the mousse is easier to use. The mousse was compared with another product (phenothrin lotion) used to get rid of lice and the wet-combing method (also known as "Bug Busting").

Who can participate?
Anyone over 4 years of age who had head lice could take part.

What does the study involve?
The participants were randomly allocated to receive one of the three treatment methods: mousse, lotion or wet-combing. The mousse and lotion treatments were applied on the first day with four follow-ups over 2 weeks to see how well they worked. The wet-combing treatment was given on four occasions 4 days apart, with follow-up checks on the 14th, 21st, and 28th days.

What are the possible benefits and risks of participating?
The possible benefit of the trial was that patients could get rid of their head lice without charge. The possible risks of the trial were discomfort or irritation where the treatment was applied either during or after the treatment.

Where is the study run from?
Medical Entomology Centre, Insect Research & Development Limited (UK)

When is the study starting and how long is it expected to run for?
June 1997 to March 1998

Who is funding the study?
Seton Healthcare Group Plc (UK)

Who is the main contact?
Mr Ian Burgess
ian@insectresearch.com

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT 100

Study information

Scientific title

A randomised controlled assessor-blind parallel group clinical trial to assess the efficacy, safety and acceptability of phenothrin mousse, phenothrin lotion and wet-comb technique in the eradication of head lice

Acronym

Study hypothesis

To compare the efficacy, safety, and acceptability of phenothrin lotion and the wet-comb technique in the eradication of head lice, and to assess whether phenothrin lotion and phenothrin mousse are equivalent in terms of efficacy, safety, and acceptability.

Ethics approval

North Bedfordshire District Ethics Committee and South Bedfordshire Research Ethics Committee

Study design

Randomised comparator-controlled assessor-blind single-centre 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 (Pediculus capitis) infestation

Intervention

1. d-phenothrin 0.5% mousse in an alcohol/water emulsifying wax base plus butane propellant supplied in 50mL pressurised containers, used once by application to dry hair for 30 minutes followed by shampoo washing.
2. d-phenothrin 0.2% lotion in an alcohol/water base supplied in 50mL bottles, used once by application to dry hair for 2 hours followed by shampoo washing.
3. Wet-combing using combs from the "Bug Buster" pack to comb out lice from shampooed and heavily conditioned hair, supplied from 1 bottle of non-medicated frequent use shampoo and 4 60mL bottles of non-medicated conditioner.

Intervention type

Drug

Phase

Not Applicable

Drug names

Phenothrin

Primary outcome measures

1. The between-treatment comparison of the number of participants with evidence of active head lice infestation 14 days after treatment.
2. In the case of the two insecticide-based treatments this meant that no lice should be found during the follow up assessments up to the 14th day after application of the product.
3. In the case of wet-combing this referred to the assessment on the 14th day after initiation of treatment and for 14 days thereafter, i.e. to the 28th day.

Secondary outcome measures

Comparison between treatments with respect to occurrence of untoward effects, whether or not they are thought to be related to the study treatment.

Overall trial start date

14/06/1997

Overall trial end date

02/03/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females over the age of 4 who are suffering from head lice
2. People who give written informed consent or, if the person is under 18 years of age, whose guardians give written informed consent to participate in the study
3. People who are available for visits from the research investigators over the following 28 days
4. People who have an adult/guardian who is able to treat or comb the hair (depending on the allocated treatment group)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

266 participants divided between treatments in the ratio 104 : 104 : 58

Participant exclusion criteria

1. People with a known sensitivity to pyrethroid insecticides and/or chrysanthemums
2. People who have been treated with other head lice products within the last 4 weeks
3. People who have any persistent skin disorder of the scalp (i.e. eczema, chronic dermatitis, psoriasis)
4. People receiving treatment for asthma
5. People who have bleached hair, or hair which has been colour treated or permed within the last 4 weeks
6. Pregnant or nursing mothers
7. People who have participated in another clinical trial within 1 month prior to entry to this study
8. People who have already participated in this clinical trial
9. People who have been treated with antibiotics within the last 4 weeks

Recruitment start date

14/06/1997

Recruitment end date

02/03/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Insect Research & Development Limited
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Organisation

Seton Healthcare Group Plc (UK)

Sponsor details

Tubiton House
Medlock Street
Oldham
OL1 3HS
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Seton Healthcare Group Plc (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25254106

Publication citations

Additional files

Editorial Notes

26/08/2016: Publication reference added.