Abstract
BackgroundTocopheryl acetate is viscous oily fluid used in a range of preparations for skin and scalp care in Italy. Observational and in vitro data have suggested a high level of efficacy against head louse infestation. The purpose of this investigation was to confirm the activity of tocopheryl acetate in a clinical setting in comparison with a standard widely used preparation.MethodsA spray formulation containing tocopheryl acetate 20% in cyclomethicone was compared with permethrin 1% creme rinse for treatment of head louse infestation in a randomised, assessor blind, trial. Forty-five people were treated on two occasions 7 days apart. The spray was applied to dry hair for 20 minutes then washed. Participants treated with permethrin washed their hair and towel dried it before treatment for 10 minutes. Assessments were made by dry detection combing 1, 6, 9, and 14 days after first treatment.ResultsThe tocopheryl acetate 20% spray was significantly (p = 0.033) more effective than permethrin 1%, using intention to treat worst case analysis, in which there were 13/23 (56.5%) successful treatments for tocopheryl acetate compared with 5/22 (22.7%) for permethrin. After unprecedented issues of re-infestation within households had been taken into account the underlying cure rate was 17/23 (73.9%) for tocopheryl acetate compared with 5/22 (22.7%), Odds Ratio 9.63 (95% CI, 2.46 to 37.68) (p < 0.001).ConclusionsThe tocopheryl acetate spray was significantly more effective than the permethrin product, was cosmetically acceptable, and not affected by current problems with resistance.Trial registrationCurrent Controlled Trials ISRCTN45553737.
Highlights
Tocopheryl acetate is viscous oily fluid used in a range of preparations for skin and scalp care in Italy
Fluid medical devices based on synthetic oils are widely used in Europe, Australia, and South America to control head lice and are generally claimed to block the respiratory structures of the insects [1,2,3,4]
Few fixed plant oils have been shown to have activity and some are relatively unstable or have only been tested in developing countries [5,6], which may explain why, in several European countries, the use of neurotoxic insecticides against head lice persists despite evidence that many of the products are no longer effective
Summary
Tocopheryl acetate has limited applications on its own because it is a high viscosity (>700 centistokes (cSt)), high surface tension (0.0337 newtons/metre (N/m)) oil, and is normally formulated in more fluid materials such as decamethylcyclopentasiloxane, a low surface tension (0.018 N/m), low viscosity (2.4 cSt) silicone solvent. This type of mixture is capable of delivering small quantities of the active substance to target sites that would otherwise be inaccessible to the viscous fluid. Few fixed plant oils have been shown to have activity and some are relatively unstable or have only been tested in developing countries [5,6], which may explain why, in several European countries, the use of neurotoxic insecticides against head lice persists despite evidence that many of the products are no longer effective
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