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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/pubmed/17987114
Publication citations
-
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.