Skin Irritation Clinical Trial
Official title:
A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)
This study is a multiple center, randomized, double-blind, vehicle-controlled, and
multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.
Subjects will be randomized prior to the first TDS application. The total duration of the
study from Screening to Follow-up is approximately 95 days for subjects participating in the
Induction Phase and the Challenge Phase of the study and potentially up to 156 days for
subjects requiring to complete 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.
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