Clinical trial NCT03397862: A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
Official title: A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Irritation
Sensitization
Lead sponsor: Corium, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-12
Enrollment: 256
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: OTHER

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 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.

Eligibility 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

Primary outcomes:
measure: Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)
timeFrame: Induction (21 days)
measure: Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)
timeFrame: Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
measure: Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)
timeFrame: 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 outcomes:
measure: Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)
timeFrame: Induction (21 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Celerion Inc.
state: Arizona
city: Lincoln
country: United States
facility: Celerion Inc.
state: Nebraska
Study officials:
affiliation: Celerion
name: Danielle Armas, MD, CPI
role: PRINCIPAL_INVESTIGATOR
affiliation: Celerion
name: Laura Sterling, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Corium International
name: Vaeling Miller
role: STUDY_DIRECTOR
References: