title: A highly efficacious pediculicide based on dimeticone: randomized observer blinded comparative trial.
abstract: BACKGROUND
  Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA(R)), as compared to a 1% permethrin lotion.
  
  
  METHODS
  Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5-15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology.
  
  
  RESULTS
  Overall cure rates were: day 2 - dimeticone 94.5% (95% CI: 86.6% - 98.5%) and permethrin 66.7% (95% CI: 54.6% - 77.3%; p < 0.0001); day 7 - dimeticone 64.4% (95% CI: 53.3% - 75.3%) and permethrin 59.7% (95% CI: 47.5% - 71.1%; p = 0.5); day 9 - dimeticone 97.2% (95% CI: 90.3% - 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group.
  
  
  CONCLUSIONS
  The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN15117709.
authors.affiliation: Department of Community Health, School of Medicine, Federal University of Ceará, Fortaleza, Brazil. heukelbach@web.de
authors.forename: Jorg
authors.initials: J
authors.lastname: Heukelbach
authors.forename: Daniel
authors.initials: D
authors.lastname: Pilger
authors.forename: Fabíola A
authors.initials: FA
authors.lastname: Oliveira
authors.forename: Adak
authors.initials: A
authors.lastname: Khakban
authors.forename: Liana
authors.initials: L
authors.lastname: Ariza
authors.forename: Hermann
authors.initials: H
authors.lastname: Feldmeier
mesh_terms: D000293:Adolescent; D000818:Animals; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D004129:Dimethylpolysiloxanes / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007306:Insecticides / Q000009:adverse effects / Q000627:therapeutic use*; D010373:Lice Infestations / Q000188:drug therapy*; D008297:Male; D010374:Pediculus / Q000187:drug effects*; D026023:Permethrin / Q000627:therapeutic use; D012536:Scalp Dermatoses / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D004129:Dimethylpolysiloxanes; D007306:Insecticides; D026023:Permethrin; C501844:dimethicone
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