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ISRCTN
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ISRCTN47755726
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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CTMK05
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Study hypothesis
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Is Hedrin 4% lotion more effective than Derbac-M liquid in the treatment of head louse infestation?
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Ethics approval
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Hertfordshire 1 Research Ethics Committee reviewed 14 August 2006 (ref.: 06/Q0201/52).
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Study design
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A randomised, controlled, assessor-blind, parallel group clinical trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Head louse infestation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2006
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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58 children and 15 adults
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Interventions
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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.
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Primary outcome measure(s)
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To compare the efficacy of Hedrin 4% lotion against Derbac-M liquid in the eradication of head lice.
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Secondary outcome measure(s)
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To compare Hedrin 4% lotion against Derbac-M liquid for safety, ease of use, and participant acceptability.
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Sources of funding
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Thornton & Ross Ltd (UK)
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/pubmed/17987114
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Contact name
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Mr
Ian
Burgess
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Address
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Medical Entomology Centre
Cambridge House
Barrington Road
Shepreth
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City/town
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Royston
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Zip/Postcode
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SG8 6QZ
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Country
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United Kingdom
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Tel
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+44 (0)1763 263011
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Fax
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+44 (0)1763 263022
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Email
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ian@insectresearch.com
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Sponsor
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Thornton & Ross Ltd (UK)
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Address
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Linthwaite
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City/town
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Huddersfield
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Zip/Postcode
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HD7 5QH
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Country
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United Kingdom
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Tel
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+44 (0)1484 842217
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Email
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steveskilleter@thorntonross.com
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Sponsor website:
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http://www.thorntonross.com/
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Date applied
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05/12/2006
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Last edited
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11/11/2008
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Date ISRCTN assigned
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27/12/2006
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