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

September 13, 2018 updated by: Corium, Inc.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85283
        • Celerion Inc.
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corplex Donepezil TDS 5 mg/day
Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.
Drug: Donepezil TDS
Donepezil patch
Placebo Comparator: Vehicle TDS
Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.
Drug: Vehicle TDS
Placebo patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)
Time Frame: Induction (21 days)
Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.
Induction (21 days)
Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)
Time Frame: Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) . The last of 48 hr or 72 hr score collected after TDS removal during the Challenge Phase will be assessed. Provided the combined score is 2 or greater, it will then be compared to the skin irritation scores collected during the induction phase. If the last Challenge Phase score is 2 or greater and generally exceeds the skin irritation scores collected during the induction phase, the subject will return for the Re-Challenge phase.
Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)
Time Frame: Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values). The last of 48 hr or 72 hr score collected after TDS removal during the Re-Challenge phase will be assessed. The subject will be considered for potential sensitization if they meet the same criteria in both Challenge phase and Re-Challenge phase (i.e. a combined score of 2 or greater at the last assessment at 48 hr or 72 hr post patch removal and the score are generally higher compared to induction phase scores.
Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)
Time Frame: Induction (21 days)
Mean cumulative skin irritation will be determined and compared between Corplex Donepezil TDS and Vehicle TDS. Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.
Induction (21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corium, Inc.

Investigators

  • Principal Investigator: Danielle Armas, MD, CPI, Celerion
  • Principal Investigator: Laura Sterling, MD, MPH, Celerion
  • Study Director: Vaeling Miller, Corium International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

March 8, 2018

Study Completion (Actual)

April 2, 2018

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-16011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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