NCT03397862

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

A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Skin Irritation
• Sensitization

Interventions

Type	Name	Description
DRUG	Donepezil TDS	Donepezil patch
DRUG	Vehicle TDS	Placebo patch

Timeline

• Start date: 2017-11-14
• Primary completion: 2018-03-08
• Completion: 2018-04-02
• First posted: 2018-01-12
• Last updated: 2018-09-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study