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Hedrin® Once vs Lyclear® against head lice
ISRCTN ISRCTN88144046
DOI 10.1186/ISRCTN88144046
ClinicalTrials.gov identifier
EudraCT number
Public title Hedrin® Once vs Lyclear® against head lice
Scientific title A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin® Once liquid gel compared with Lyclear®1% permethrin creme rinse in the treatment of head lice
Acronym N/A
Serial number at source CTMK13
Study hypothesis To confirm that Hedrin® Once is effective to kill head lice and their eggs with a single application, in comparison with two applications of Lyclear® and to identify any significant difference in performance (superiority) of one product over the other in the eradication of head lice.
Lay summary Not provided at time of registration
Ethics approval Central London Research Ethics Committee 2 to be reviewed on the 04/05/2011 (ref: 11/LO/0455) - Approval pending as of 19/04/2011
Study design Single-centre randomised two-arm comparative study
Countries of recruitment United Kingdom
Disease/condition/study domain Head louse infestation
Participants - inclusion criteria 1. Both males and females, aged 6 months and over with no upper age limit
2. People who upon examination, are confirmed to have live head lice
3. People 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. People who will be available for follow-up visits by 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® Once liquid gel or Lyclear® 1% permethrin creme rinse, pyrethroid insecticides, or plants related to dandelions or chrysanthemums.
2. People with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition (e.g. psoriasis of the scalp)
3. People who have been treated with other head lice products within the previous two weeks
4. People who have bleached hair, or hair that has been permanently waved within the previous four weeks
5. People who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
6. Pregnant or nursing mothers
7. People who have participated in another clinical study within one month before entry to this study
8. People who have already participated in this clinical study
Anticipated start date 01/06/2011
Anticipated end date 31/10/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 84 (randomised by household) from an estimated 44 households, divided into two groups of 42
Interventions Group A: Hedrin® Once liquid gel , applied for 15 minutes before washing off using shampoo, applied one one occasion only.

Group B: Lyclear® 1% permethrin creme rinse, applied for 10 minutes to pre-washed and towel dried hair before rinsing off with water, with a repeat treatment one week later.
Primary outcome measure(s) 1. To demonstrate cure of infestation, defined as no evidence of head lice.
1.1. For Hedrin® Once following a single 15 minute application up to day 14
1.2. For Lyclear® creme rinse using two applications assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment for both products being applied on day 0).
Secondary outcome measure(s) 1. To compare the efficacy of Hedrin® Once with Lyclear® creme rinse and to identify superiority of one product over the other if appropriate.
2. Safety of the products monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study
Sources of funding Thornton & Ross Ltd (UK)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23548062
Contact name Mr  Ian F  Burgess
  Address Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
  City/town Cambridge
  Zip/Postcode CB25 9AU
  Country United Kingdom
  Tel +44 (0)122 381 0070
  Fax +44 (0)122 381 0078
  Email ian@insectresearch.com
Sponsor Thornton & Ross Ltd (UK)
  Address Linthwaite Laboratories
Linthwaite
  City/town Huddersfield
  Zip/Postcode HD7 5QH
  Country United Kingdom
  Tel +44 (0)148 484 2217
  Fax +44 (0)148 484 7301
  Email ashleybrierley@thorntonross.com
  Sponsor website: http://www.thorntonross.com
Date applied 19/04/2011
Last edited 27/08/2013
Date ISRCTN assigned 24/05/2011
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