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

NCT03397862 | Completed Phase 1 FDA Drug

• 1 other identifier: P-16011
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Skin Irritation; Sensitization

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (1)

• Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)

  Induction (21 days)

Study Arms (2)

Corplex Donepezil TDS 5 mg/day

EXPERIMENTAL

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

Drug: Donepezil TDS

Vehicle TDS

PLACEBO COMPARATOR

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

Drug: Vehicle TDS

Interventions

Donepezil TDS DRUG

Donepezil patch

Corplex Donepezil TDS 5 mg/day

Vehicle TDS DRUG

Placebo patch

Vehicle TDS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corium, Inc.: lead

Study Sites (2)

Celerion Inc.

Phoenix, Arizona, 85283, United States

Location

Celerion Inc.

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Danielle Armas, MD, CPI

  Celerion

  PRINCIPAL INVESTIGATOR

• Laura Sterling, MD, MPH

  Celerion

  PRINCIPAL INVESTIGATOR

• Vaeling Miller

  Corium International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will occur at package level.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: January 12, 2018
• Study Start: November 14, 2017
• Primary Completion: March 8, 2018
• Study Completion: April 2, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)