Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- IGA
研究概览
简要总结
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).
详细描述
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.
Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement and Visual Analog Scale for itch. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline.
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 (parent permission and assent if applicable).
- •Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
- •Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
- •Percentage of overall body surface area of involvement (BSA) must be ≥2%.
- •Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.
排除标准
- •Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
- •Application or use within two weeks of Baseline 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.
- •Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
- •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
- •Women who are breastfeeding
研究组 & 干预措施
Fluocinonide cream
Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
干预措施: Fluocinonide cream (Drug)
结局指标
主要结局
IGA
时间窗: 14 days
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
次要结局
- EASI(14 days)
- BSA(14 days)
- VAS(14 days)
- Actigraphy(14 days)