Abstract
BackgroundThe increase in resistance of head lice to neurotoxic pediculicides and public concern over their safety has led to an increase in alternative treatments, many of which are poorly researched or even untested.MethodsA multicentre, randomised, assessor‐blind, parallel‐group trial (Trial 1) was conducted to compare the safety and efficacy of a head lice treatment containing Australian eucalyptus oil and Leptospermum petersonii (EO/LP solution; applied thrice with 7‐day intervals between applications) with a neurotoxic treatment containing pyrethrins and piperonyl butoxide (P/PB mousse; applied twice with a 7‐day interval) in children. A single‐blind, open trial (Trial 2) was conducted to assess the efficacy of EO/LP solution following a single application. In addition, skin irritancy and sensitisation tests using EO/LP solution were performed in adults and children. In vitro tests were performed to further assess the ovicidal and pediculicidal efficacy of EO/LP solution.ResultsEO/LP solution was found to be more than twice as effective in curing head lice infestation as P/PB mousse in per‐protocol participants (Trial 1; 83% vs 36%, P < 0.0001), and was also found to be 100% pediculicidal following a single application (Trial 2). Adverse events were limited to transient itching, burning or stinging. Further skin testing with the EO/LP solution reported no irritation or sensitisation in adults, or irritation in children. In vitro exposure of lice and eggs to the EO/LP solution resulted in 100% mortality.ConclusionThe efficacy, safety and relative ease of use of the EO/LP solution make it a viable alternative in treating head lice.
Highlights
Infestation with head lice is one of the most common parasitic infestations of humans worldwide.[1]
Reasons for a participant being deemed not PP were: they did not receive the required dose (1 vs 0 for the eucalyptus oil and Leptospermum petersonii (EO/LP) solution and piperonyl butoxide (P/PB) mousse, respectively); they used alternative head lice treatments during the trial (1 vs 2); they failed to comply with sibling control criteria (5 vs 10); they failed to appear for assessment at day 21 (1 vs 0)
One participant treated with the EO/LP solution withdrew from the trial due to an adverse event
Summary
Infestation with head lice is one of the most common parasitic infestations of humans worldwide.[1]. Methods: A multicentre, randomised, assessorblind, parallel-group trial (Trial 1) was conducted to compare the safety and efficacy of a head lice treatment containing Australian eucalyptus oil and Leptospermum petersonii (EO/LP solution; applied thrice with 7-day intervals between applications) with a neurotoxic treatment containing pyrethrins and piperonyl butoxide (P/PB mousse; applied twice with a 7-day interval) in children. Skin irritancy and sensitisation tests using EO/LP solution were performed in adults and children. In vitro tests were performed to further assess the ovicidal and pediculicidal efficacy of EO/LP solution. Results: EO/LP solution was found to be more than twice as effective in curing head lice infestation as P/PB mousse in per-protocol participants (Trial 1; 83% vs 36%, P < 0.0001), and was found to be 100% pediculicidal following a single application (Trial 2). In vitro exposure of lice and eggs to the EO/LP solution resulted in 100% mortality
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