Is Hedrin 4% effective in 1 hour?

• Research type

  Research Study

• Full title

  A proof of concept clinical investigation to evaluate the activity of Hedrin 4% lotion in the treatment of head lice using a 1 hour application time

• Contact name

  Ian F Burgess

• Sponsor organisation

  Thornton & Ross Ltd

• Eudract number

  2008-005787-13

• ISRCTN Number

  finished

• Research summary

  Hedrin 4% lotion has demonstrated efficacy in two randomised, controlled, comparative trials. The current treatment regimen is two applications for 8 hours or overnight with a week between. However, most carers prefer to use shorter application times and evidence from a small Phase II study suggested this would be possible. The aim of this study is to determine whether Hedrin 4% lotion can be used successfully for a shorter application time (1 hour) in the eradication of head louse infestation than the currently approved 8 hours or overnight application, and to evaluate the treatment regimen with regard to safety, ease of application, and participant acceptability. Forty (40) evaluable participants, minimum age 6 months, who upon examination are confirmed to have head lice and who fit the selection criteria will be recruited to the study. A member of the Medical Entomology Centre study team will apply the treatment, which will be left on for 1 hour. Participants (or their carers) will be asked to shampoo the treatment off after 1 hour with normal shampoo (this will be supplied). Each participant will be visited at home to assess the effectiveness of the treatment and to monitor any adverse events that occur. Participants will be on the study for a total of 15 days, and four post treatment assessments will be made during this time. The final assessment will be 14 days after the treatment was initially applied. Participants who still have evidence of head lice at the end of the study will be offered Hedrin 4% lotion as a standard of care treatment.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  08/H0301/114

• Date of REC Opinion

  27 Oct 2008

• REC opinion

  Further Information Favourable Opinion