Prospective, Randomized, Investigator-Blind, Controlled, Pilot Study Comparing Effect of Epiceram™ Device vs Standard of Care Therapy of Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) in Treatment of Atopic Dermatitis in Pediatric Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
研究概览
简要总结
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages > 7 to 18 years and parental consent for ages 6 months to 7 years) to participate in the study
- •Males or Females
- •Age: 6 months to 18 years
- •Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index
排除标准
- •Subjects with mild AD as defined by the Rajka-Laneland Severity Index.
- •Subjects having greater than 20% BSA as measured by SCORAD "Extent" (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%)
- •Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- •Subjects who require greater than 2mg per day of inhaled or intranasal steroids.
- •Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month.
- •Subjects with known allergy to or hypersensitivity to EpiCeram™ or Fluticasone or Cetaphil.
- •Active infection of any type at the start of the study.
研究组 & 干预措施
Cutivate(r)
Topical mid-strength steroid
干预措施: Fluticasone Propionate 0.05% (Drug)
EpiCeram(r)
EpiCeram(r) topical barrier repair cream.
干预措施: Epiceram(r) (Device)
结局指标
主要结局
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
时间窗: 4 weeks
次要结局
- Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)(4 weeks)
- Change in assessments of Pruritus and sleep habits(week 4)