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A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System

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

Clinical Trial Summary

A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03397862
Study type Interventional
Source Corium International Inc.
Contact
Status Completed
Phase Phase 1
Start date November 14, 2017
Completion date April 2, 2018
View Details
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