title: [Randomised clinical trial to evaluate the efficacy and safety of a new pediculicide made with saponified olive oil in the eradication of Pediculus humanus capitis].
abstract: BACKGROUND
  The aim of the study was to evaluate the efficacy and safety of a new pediculicide in the eradication of Pediculus humanus capitis infestation.
  
  
  METHODS
  A randomised clinical trial was designed, in which children aged between 5 and 15 years diagnosed with pediculosis were selected. Treatment was administered on days 1 and 7 after selection, and they were evaluated in 4 visits (day 2, 7, 9, and 14). The product under evaluation with saponified olive oil was Inex Pediculicide Soap®, which was compared with Paranix®, with a similar mechanism of action. The primary efficacy endpoint was the eradication of the parasite by day 14 (louse-free rate), using an intention to treat analysis.
  
  
  RESULTS
  Six paediatricians from 5 Primary Health Care centres in the Community of Madrid (Spain) and one private clinic participated in the study. A total of 45 children were included, of which 75.6% were girls (n=34). The mean age was 7.1 years (95% CI 6.3-7.9). The large majority (80%) were middle class, and 82.2% had a history of previous pediculosis. The efficacy at 14 days was 76.2% (95% CI 52.8-91.8) in the group treated with Inex Pediculicide Soap®group, and 79.2% (95% CI 57.9-92.9) in Paranix®group (NNT=33.3). No adverse effects were observed with treatment.
  
  
  CONCLUSIONS
  The 2 products were effective and safe in the eradication therapy Pediculus humanus capitis, with no statistical differences.
authors.affiliation: Departamento Médico, E-C-BIO, S. L., Madrid, España. Electronic address: bsoler@ecbio.net.
authors.forename: B
authors.initials: B
authors.lastname: Soler
authors.affiliation: Centro de Salud Santa Mónica, Rivas-Vaciamadrid, Madrid, España.
authors.forename: C
authors.initials: C
authors.lastname: Castellares
authors.affiliation: Centro de Salud Valle de la Oliva, Majadahonda, Madrid, España.
authors.forename: S
authors.initials: S
authors.lastname: Viver
authors.affiliation: Clínica CEMECO, Torrelodones, Madrid, España.
authors.forename: L
authors.initials: L
authors.lastname: Díaz
authors.affiliation: Centro de Salud Santa Mónica, Rivas-Vaciamadrid, Madrid, España.
authors.forename: R
authors.initials: R
authors.lastname: Gómez
authors.affiliation: Centro de Salud María Jesús Hereza Cuéllar, Leganés, Madrid, España.
authors.forename: E
authors.initials: E
authors.lastname: Ruíz
mesh_terms: D000293:Adolescent; D000818:Animals; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007306:Insecticides / Q000008:administration & dosage* / Q000009:adverse effects; D010373:Lice Infestations / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D000069463:Olive Oil / Q000737:chemistry*; D010374:Pediculus / Q000187:drug effects; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000469:parasitology; D013030:Spain; D016896:Treatment Outcome
chemical_list: D007306:Insecticides; D000069463:Olive Oil
keywords: Clinical trial; Ensayo clínico; Liendre; Louse; Nit; Pediculicida; Pediculicide; Pediculus humanus capitis; Piojo