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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05565820
Study type Interventional
Source Alliance Pharmaceuticals
Contact Tim H Rivera
Phone 305-387-0081
Email trivera@sffhrc.com
Status Recruiting
Phase Phase 4
Start date December 15, 2022
Completion date March 2023

See also
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