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

Corium

Status and phase: Completed; Phase 1

Conditions: Sensitization; Skin Irritation

Treatments: Drug: Vehicle TDS; Drug: Donepezil TDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03397862

P-16011

Details and patient eligibility

About

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

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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256 participants in 2 patient groups, including a placebo group

Corplex Donepezil TDS 5 mg/day

Experimental group

Description:

Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.

Treatment:

Drug: Donepezil TDS

Vehicle TDS

Placebo Comparator group

Description:

Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.

Treatment:

Drug: Vehicle TDS