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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-14

Study Completion Date

2018-04-02

Brief Summary

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

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Detailed Description

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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

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Skin Irritation Sensitization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Induction Phase will consist of application of the once-weekly TDS for 3 consecutive weeks to the same skin site, followed by a rest period of 2 weeks. The TDS application site will be visually scored for skin irritation approximately 30 minutes following each patch removal and prior to the next patch application. The Challenge Phase will consist of 2 days of TDS application followed by 3 days of visual scoring of TDS application site following TDS removal. Subjects meeting the guidance criteria for Re-Challenge phase will continue with a rest period of 4-8 weeks, followed by 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinding will occur at package level.

Study Groups

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Corplex Donepezil TDS 5 mg/day

Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.

Group Type EXPERIMENTAL

Donepezil TDS

Intervention Type DRUG

Donepezil patch

Vehicle TDS

Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.

Group Type PLACEBO_COMPARATOR

Vehicle TDS

Intervention Type DRUG

Placebo patch

Interventions

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Donepezil TDS

Donepezil patch

Intervention Type DRUG

Vehicle TDS

Placebo patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, adult, male or female
* Body mass index ≥ 18.0 and ≤ 35.0 kg/m2
* Medically healthy, as deemed by the Investigator
* Have a skin type with Fitzpatrick scale score of I, II, or III

Exclusion Criteria

* History or presence of alcoholism or drug abuse
* History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds
* Positive urine drug or alcohol results
* Female subjects with a positive pregnancy test or who are lactating
* Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study:

1. Inducers of cytochrome enzymes and/or P-glycoprotein
2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics
3. Beta-blockers
4. Cholinergics and anticholinergics
5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications
* History or presence of significant skin damage deemed by the investigator to potentially interfere
* Any medical or surgical procedure or trauma
* Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes