Condition category
Infections and Infestations
Date applied
05/12/2006
Date assigned
27/12/2006
Last edited
11/11/2008
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
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
+44 (0)1763 263011
ian@insectresearch.com

Additional identifiers

EudraCT number

2006-004136-73

ClinicalTrials.gov number

Protocol/serial number

CTMK05

Study information

Scientific title

Acronym

Study hypothesis

Is Hedrin 4% lotion more effective than Derbac-M liquid in the treatment of head louse infestation?

Ethics approval

Hertfordshire 1 Research Ethics Committee reviewed 14 August 2006 (ref.: 06/Q0201/52).

Study design

A randomised, controlled, assessor-blind, parallel group clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Head louse infestation

Intervention

Dimeticone 4% lotion (Hedrin 4% lotion): The product will be applied directly to dry hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for eight hours (or overnight) before being shampooed and rinsed off with water. The product will be reapplied at day seven.

Malathion 0.5% aqueous emulsion (Derbac-M liquid): The product will be applied directly to dry hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for eight hours (or overnight) before being shampooed and rinsed off with water. The product will be reapplied at day seven.

Intervention type

Drug

Phase

Not Specified

Drug names

Hedrin and Derbac-M

Primary outcome measures

To compare the efficacy of Hedrin 4% lotion against Derbac-M liquid in the eradication of head lice.

Secondary outcome measures

To compare Hedrin 4% lotion against Derbac-M liquid for safety, ease of use, and participant acceptability.

Overall trial start date

01/10/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants aged six months 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

Other

Gender

Not Specified

Target number of participants

58 children and 15 adults

Participant exclusion criteria

1. Participants with a known sensitivity to any of the ingredients in Hedrin 4% lotion or Derbac-M liquid
2. 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)
3. Participants who have been treated with other head lice products within the previous two weeks
4. 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)
5. Participants 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
6. Pregnant or nursing mothers
7. Participants who have participated in another clinical study within one month before entry to this study
8. Participants who have already participated in this clinical study

Recruitment start date

01/10/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom

Sponsor information

Organisation

Thornton & Ross Ltd (UK)

Sponsor details

Linthwaite
Huddersfield
HD7 5QH
United Kingdom
+44 (0)1484 842217
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

Results in: http://www.ncbi.nlm.nih.gov/pubmed/17987114

Publication citations

  1. Results

    Burgess IF, Lee PN, Matlock G, Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation., PLoS ONE, 2007, 2, 11, e1127, doi: 10.1371/journal.pone.0001127.

Additional files

Editorial Notes