[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].
| Autor: | Soler B; Departamento Médico, E-C-BIO, S. L., Madrid, España. Electronic address: bsoler@ecbio.net., Castellares C; Centro de Salud Santa Mónica, Rivas-Vaciamadrid, Madrid, España., Viver S; Centro de Salud Valle de la Oliva, Majadahonda, Madrid, España., Díaz L; Clínica CEMECO, Torrelodones, Madrid, España., Gómez R; Centro de Salud Santa Mónica, Rivas-Vaciamadrid, Madrid, España., Ruíz E; Centro de Salud María Jesús Hereza Cuéllar, Leganés, Madrid, España. |
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| Jazyk: | Spanish; Castilian |
| Zdroj: | Semergen [Semergen] 2017 Mar; Vol. 43 (2), pp. 91-99. Date of Electronic Publication: 2016 May 30. |
| DOI: | 10.1016/j.semerg.2016.03.009 |
| Abstrakt: | Introduction: The aim of the study was to evaluate the efficacy and safety of a new pediculicide in the eradication of Pediculus humanus capitis infestation. Material and 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. (Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.) |
| Databáze: | MEDLINE |
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