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Trial record 2 of 332 for:    DONEPEZIL

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

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ClinicalTrials.gov Identifier: NCT03397862
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Corium International Inc.

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

Condition or disease Intervention/treatment Phase
Skin Irritation Sensitization Drug: Donepezil TDS Drug: Vehicle TDS Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinding will occur at package level.
Primary Purpose: Other
Official Title: A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397862


Locations
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United States, Arizona
Celerion Inc.
Phoenix, Arizona, United States, 85283
United States, Nebraska
Celerion Inc.
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Corium International Inc.
Investigators
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Principal Investigator: Danielle Armas, MD, CPI Celerion
Principal Investigator: Laura Sterling, MD, MPH Celerion
Study Director: Vaeling Miller Corium International

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Responsible Party: Corium International Inc.
ClinicalTrials.gov Identifier: NCT03397862     History of Changes
Other Study ID Numbers: P-16011
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents