A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Corium, Inc.
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)
研究概览
简要总结
A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding will occur at package level.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Corplex Donepezil TDS 5 mg/day
Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.
干预措施: Donepezil TDS (Drug)
Vehicle TDS
Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.
干预措施: Vehicle TDS (Drug)
结局指标
主要结局
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)
时间窗: Induction (21 days)
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.
Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)
时间窗: Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
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.
Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)
时间窗: 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
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.
次要结局
- Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)(Induction (21 days))