A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
研究概览
简要总结
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease.
The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.
详细描述
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Current standard of care for atopic dermatitis includes topical corticosteroids and calcineurin inhibitors, such as Elidel and Protopic. The chronic use of topical corticosteroids is limited by side effects including skin atrophy, striae, and even HPA axis suppression. The long-term effects of skin immunosuppression with calcineurin inhibitors are unknown and although not proven, a theoretical risk of skin cancer exists. Novel therapies for atopic dermatitis that avoid immunosupression are greatly needed.
Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease. The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females of any race 2 - 12 years of age.
- •Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
- •Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
- •At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.
排除标准
- •Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
- •Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
- •Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- •Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- •Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
- •Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
- •Active infection of any type at the start of the study.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- •Subjects must have not used any topical or systemic therapy during the washout periods.
研究组 & 干预措施
Elidel(r)
干预措施: Elidel(R) (pimecrolimus 1%) (Drug)
Epiceram(r)
干预措施: EpiCeram(R) -ceramide based barrier repair cream (Device)
结局指标
主要结局
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
时间窗: 4 weeks
次要结局
- Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.(4 weeks)
- Change in mean capacitance in lesional and nonlesional skin at target site(4 weeks)
- Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site(4 weeks)
- Change in pruritus score measured with a visual analog scale(4 weeks)
- Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)(4 weeks)