Status:
COMPLETED
A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
Lead Sponsor:
Corium, Inc.
Conditions:
Skin Irritation
Sensitization
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief 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 randomize...
Eligibility Criteria
Inclusion
- 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
- 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:
- Inducers of cytochrome enzymes and/or P-glycoprotein
- Anti-inflammatory drugs or cyclooxygenase 2 analgesics
- Beta-blockers
- Cholinergics and anticholinergics
- 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
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT03397862
Start Date
November 14 2017
End Date
April 2 2018
Last Update
September 14 2018
Active Locations (2)
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1
Celerion Inc.
Phoenix, Arizona, United States, 85283
2
Celerion Inc.
Lincoln, Nebraska, United States, 68502