02704nas a2200253 4500008004100000245010200041210006900143260001400212300001400226490000700240520191700247653001602164653002002180100001902200700003102219700001602250700001702266700002002283700002302303700001802326700002102344700002202365856006302387 2018 eng d00aClinical studies evaluating abametapir lotion, 0.74%, for the treatment of head louse infestation0 aClinical studies evaluating abametapir lotion 074 for the treatm cJuly 2018 a616 - 6210 v353 a

Background: There is a need for better control of head louse infestations. Abameta- pir is an inhibitor of metalloproteinases critical for louse survival and egg develop- ment. The efficacy of abametapir lotion, 0.74%, was assessed for its ability to clear head louse infestations after a single application.
Methods: Two randomized, double‐blind, multicenter, vehicle‐controlled studies were conducted in subjects aged 6 months and older to compare the effectiveness of abametapir lotion versus vehicle control for eliminating head louse infestations without nit combing. Abametapir lotion was applied to dry hair for 10 minutes on day 0 and then rinsed with water. The primary endpoint was the proportion of index subjects (youngest household member with ≥ 3 live lice at screening) in the intent‐ to‐treat population who were louse free at all follow‐up visits through day 14. Older household members with one or more live lice at screening were designated as non- index subjects and treated as per the index subject within their household.
Results: In the intent‐to‐treat population (index subjects, N = 216), 81.5% of sub- jects treated with abametapir lotion were louse free through day 14 after a single treatment, versus 49.1% with vehicle (P < 0.001). For the combined index and non- index population (N = 704), 85.9% were louse free through day 14 in the abameta- pir group, versus 61.3% in the vehicle group (P < 0.001). The most frequently reported adverse events were erythema (4.0%), rash (3.2%), and skin burning sensa- tion (2.6%).
Conclusion: Abametapir lotion, 0.74%, was effective at clearing active head louse infestations through day 14 in subjects aged 6 months and older. All adverse events (including one serious but unrelated to study drug) resolved uneventfully.

10aInfestation10atherapy-topical1 aBowles, V., M.1 aVan_Luvanee, Lisa, Jenkins1 aAlsop, Hugh1 aHazan, Lydie1 aShepherd, Katie1 aSidgiddi, Srinivas1 aAllenby, Kent1 aAhveninen, Tiina1 aHanegraaf, Sharon uhttps://onlinelibrary.wiley.com/doi/full/10.1111/pde.13612