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A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)
Multiple center, vehicle-controlled, randomized, double-blind and multiple-dose study.
Subjects will be randomized prior to the first TDS application. Total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating from the Induction Phase to the Challenge Phase and potentially up to 156 days for subjects further participating in the Re-Challenge Phase.
Skin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.
Donepezil TDS, Vehicle TDS
Corium International Inc.
Published on BioPortfolio: 2018-01-19T11:17:09-0500
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