Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin barrier biophysical properties
研究概览
简要总结
This proposed project will be an open-label, split face, randomized controlled pilot study. Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The purpose of this study is to understand the change in skin appearance throughout 5-FU treatment course and to examine whether a topical corticosteroid and moisturizer can decrease severity and duration of skin inflammation after 5-FU treatment course.
详细描述
The purpose of this study to understand the change in skin appearance during and after the course of 5-FU cream in patients with AK, and compare how the appearance of skin inflammation changes with the use of topical corticosteroids and moisturizers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, at least 18 years of age
- •Subject must have a diagnosis of actinic keratosis (at least 5 lesions on each side of the face)
- •Able to comprehend and read the English language
排除标准
- •Subjects who do not fit the inclusion criteria
- •Concurrently have other inflammatory skin conditions.
- •Prior known allergy to any components to of 5FU cream, topical steroid ointment or vaseline.
- •Subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures (i.e.: compliant with using 5-FU cream, topical corticosteroid or moisturizers
- •Those that are prisoners or cognitively impaired.
研究组 & 干预措施
Topical Steroid Ointment
One side of the face will receive a Topical Steroid ointment twice daily for seven days.
干预措施: Topical Steroid Ointment (Drug)
Vaseline
One side of the face will receive Vaseline twice daily for seven days.
干预措施: Vaseline (Other)
Skin Barrier Moisturizer
One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
干预措施: Skin Barrier Moisturier (Drug)
结局指标
主要结局
Skin barrier biophysical properties
时间窗: 2 hours
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)
次要结局
未报告次要终点