Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Eczema Severity and Area Index
研究概览
简要总结
The purpose of this study is to determine the effect of short-term therapy using "VANOS Cream," a super-potent topical steroid cream on skin barrier function in patients with atopic dermatitis. This cream is already approved for this indication, but the investigators will further examine its effects on the skin barrier. This cream is a novel formulation of fluocinonide designed to enhance compliance with a cream base, but have the skin barrier repair properties of an ointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B)
- •Age 12 years or older
- •Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very Severe (See Appendix C)
- •Must have failed to achieve adequate disease despite adequate topical or systemic therapy
- •Must be a candidate, according to the principal investigator and standard of care, for a super-potent topical steroid course. Subjects that are candidates for super-potent topical steroids are defined as subjects whose disease is not adequately controlled with medium-potency topical steroids or systemic therapy, including phototherapy.
排除标准
- •Active skin infection
- •Hypersensitivity to any ingredients in Vanos cream
- •Previous use of super-potent topical steroids within 2 weeks of starting study (Class I steroid).
研究组 & 干预措施
Vanos Cream
glucocorticoid cream
干预措施: Fluocinonide (Drug)
结局指标
主要结局
Change in Eczema Severity and Area Index
时间窗: 2 Weeks
The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.
次要结局
- Change in Transepidermal Water Loss(2 weeks)
研究者
Eric Simpson
Professor, Dermatology
Oregon Health and Science University