Head Lice Clinical Trial
Official title:
Treatment of Infestation With Pediculus Humanus Capitis in the Community Using a leave-in Spray: A Prospective, Randomised Controlled Study
The purpose of this study is to evaluate the safety and efficacy of Vamousse Spray 'n' Go, compared to a 1% Permethrin control shampoo, in the treatment of head lice.
Effective methods for eradication of lice infestation are available however many are time consuming to use and require diligence; ineffective application of treatments has led to the spread of resistant strains. This is a post-marketing, prospective, open label, randomised controlled study to evaluate the safety and efficacy of Vamousse Spray 'n' Go in subjects infested with Pediculosis Capitis. The product contains a broad spectrum antiparasitic, which may have a unique mode of action, and has a simple and convenient application method. The primary objective of the study will explore whether treatment with Vamousse Spray 'n' Go is more effective in killing lice and eggs compared to a permethrin-based control product. The secondary objective of the study is to demonstrate the safety and local tolerability of Vamousse Spray 'n' Go in children ages 2 years plus. The planned sample size is 58 subjects, equally split between treatment and control groups. Subjects will receive the allocated product on day 0, with follow-up visits on days 2, 7 and 14. A repeat treatment will be administered on day 7 if live lice are still present. ;
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