title: Prevention of head louse infestation: a randomised, double-blind, cross-over study of a novel concept product, 1% 1,2-octanediol spray versus placebo.
abstract: OBJECTIVE
  To determine whether regular use of a spray containing 1,2-octanediol 1%, which has been shown to inhibit survival of head lice, is able to work as a preventive against establishment of new infestations.
  
  
  METHODS
  Randomised, double-blind, cross-over, community study in Cambridgeshire, UK.
  
  
  METHODS
  63 male and female schoolchildren aged 4-16 years judged to have a high risk of recurrent infestation. Only the youngest member of a household attending school participated.
  
  
  METHODS
  Participants were treated to eliminate lice, randomised between 1% octanediol or placebo sprays for 6 weeks then crossed-over to the other spray for 6 weeks. Parents applied the sprays at least twice weekly or more frequently if the hair was washed. Investigators monitored weekly for infestation and replenished supplies of spray.
  
  
  METHODS
  The primary endpoint was the time taken until the first infestation event occurred. The secondary measure was safety of the product in regular use.
  
  
  RESULTS
  Intention-to-treat analysis found a total of 32 confirmed infestations in 20 participants, with 9 of them infested while using both products. In these nine participants the time to first infestation showed a significant advantage to 1% octanediol (p=0.0129). Per-protocol analysis showed only trends because the population included was not large enough to demonstrate significance. There were no serious adverse events and only two adverse events possibly related to treatment, one was a case of transient erythema and another of a rash that resolved after 5 days.
  
  
  CONCLUSIONS
  Routine use of 1% octanediol spray provided a significant level of protection from infestation. It was concluded that this product is effective if applied regularly and thoroughly.
  
  
  BACKGROUND
  ISRCTN09524995.
authors.affiliation: Medical Entomology Centre, Insect Research & Development Limited, Cambridge, UK.
authors.forename: Ian F
authors.initials: IF
authors.lastname: Burgess
authors.affiliation: Medical Entomology Centre, Insect Research & Development Limited, Cambridge, UK.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Brunton
authors.affiliation: Medical Entomology Centre, Insect Research & Development Limited, Cambridge, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: French
authors.affiliation: Medical Entomology Centre, Insect Research & Development Limited, Cambridge, UK.
authors.forename: Nazma A
authors.initials: NA
authors.lastname: Burgess
authors.forename: Peter N
authors.initials: PN
authors.lastname: Lee