Hedrin Once versus Lyclear against head lice

• Research type

  Research Study

• Full title

  A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin® Once liquid gel compared with Lyclear 1% permethrin crème rinse in the treatment of head lice

• IRAS ID

  75762

• Contact name

  Ian Burgess

• Sponsor organisation

  Thornton & Ross Ltd

• Eudract number

  2011-000257-23

• ISRCTN Number

  not sent

• Research summary

  This is a randomised, controlled, assessor blinded investigation to compare the efficacy of a class I Medical Device with a widely used medicinal product in the elimination of head louse infestation. The aim is to confirm efficacy data for Hedrin Once obtained previously.Eighty-four participants, minimum age 6 months, with confirmed head louse infestation will be divided between the two treatment groups.At the first visit (Day 0), investigators will check for the presence of live head lice using a fine??toothed plastic detection comb. Participants may be enrolled to the study provided they fit the inclusion/exclusion criteria.Participants (or parents/guardians if younger than 16 years) will sign a Consent Form before participation in the study. There will be a separate Assent Form for children capable of giving written assent, which will be witnessed by the parent/guardian. Consent will include permission to inform the participant's GP of their participation. Infested household members unable to participate in the study will be offered a standard of care treatment to reduce reinfestation of participants during the study.Each household will be allocated a study number from a randomised treatment allocation sequence, and each individual a numerical identifier. All participants in the house will receive the same treatment. Treatments are:Hedrin Once liquid gel applied to dry hair for 15 minutes on Day 0 of the study only.Lyclear 1% permethrin crÇùme rinse applied for 10 minutes to washed and dried hair on two occasions a week apart (Day 0 and Day 7).Investigators will apply the treatment. Participants will be assessed on Days 1, 6, 9 and 14 (?? 1 day) by different investigators. Any lice recovered will be taped into the participant's CRF.All adverse events will be monitored during the study and all changes in concomitant illness and medication will be recorded.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/0455

• Date of REC Opinion

  14 Jun 2011

• REC opinion

  Further Information Favourable Opinion