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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03397862
Other study ID # P-16011
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 14, 2017
Est. completion date April 2, 2018

Study information

Verified date September 2018
Source Corium International Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date April 2, 2018
Est. primary completion date March 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Donepezil TDS
Donepezil patch
Vehicle TDS
Placebo patch

Locations

Country Name City State
United States Celerion Inc. Lincoln Nebraska
United States Celerion Inc. Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Corium International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase) 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)
Primary Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase) 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
Primary Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase) 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 Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase) 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)
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