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A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin 4% dimeticone lotion compared with Derbac-M 0.5% malathion aqueous liquid in the treatment of head lice
ISRCTN ISRCTN47755726
DOI 10.1186/ISRCTN47755726
ClinicalTrials.gov identifier
EudraCT number 2006-004136-73
Public title A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin 4% dimeticone lotion compared with Derbac-M 0.5% malathion aqueous liquid in the treatment of head lice
Scientific title
Acronym N/A
Serial number at source CTMK05
Study hypothesis Is Hedrin 4% lotion more effective than Derbac-M liquid in the treatment of head louse infestation?
Lay summary
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.
Countries of recruitment United Kingdom
Disease/condition/study domain Head louse infestation
Participants - 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
Participants - 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
Anticipated start date 01/10/2006
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants 58 children and 15 adults
Interventions 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.
Primary outcome measure(s) To compare the efficacy of Hedrin 4% lotion against Derbac-M liquid in the eradication of head lice.
Secondary outcome measure(s) To compare Hedrin 4% lotion against Derbac-M liquid for safety, ease of use, and participant acceptability.
Sources of funding Thornton & Ross Ltd (UK)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/pubmed/17987114
Contact name Mr  Ian  Burgess
  Address Medical Entomology Centre
Cambridge House
Barrington Road
Shepreth
  City/town Royston
  Zip/Postcode SG8 6QZ
  Country United Kingdom
  Tel +44 (0)1763 263011
  Fax +44 (0)1763 263022
  Email ian@insectresearch.com
Sponsor Thornton & Ross Ltd (UK)
  Address Linthwaite
  City/town Huddersfield
  Zip/Postcode HD7 5QH
  Country United Kingdom
  Tel +44 (0)1484 842217
  Email steveskilleter@thorntonross.com
  Sponsor website: http://www.thorntonross.com/
Date applied 05/12/2006
Last edited 11/11/2008
Date ISRCTN assigned 27/12/2006
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