An Open-Label Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
研究概览
简要总结
The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.
详细描述
This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.
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
- •Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (and assent if applicable)
- •Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))
- •Percentage of overall body surface are of involvement (BSA) must be ≥2%
- •Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control
排除标准
- •Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
- •Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome
- •Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments
- •Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study
- •Amount of disease involvement that would require >60 gm of cream in a 1 week period
- •Subjects with known allergy or sensitivity to topical Vanos™ cream or components
- •Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
研究组 & 干预措施
Fluocinonide Cream 0.1%
Fluocinonide Cream 0.1% open label
干预措施: Fluocinonide Cream 0.1% (Drug)
结局指标
主要结局
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
时间窗: Baseline to 3 days
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
次要结局
- Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.(Baseline to 14 days)