Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in microvesicle particle levels from baseline in clinically photosensitive subjects
研究概览
简要总结
The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and Male adult subjects age 18 to 50
- •Must be able to give informed consent
- •Have access to stable transportation
- •All skin types on Fitzpatrick Scale (Type I-VI)
- •Self-Identified photosensitivity
- •Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer.
排除标准
- •Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
- •Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- •Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
- •Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)
- •Large tattoos in the designated testing areas
- •Tanning bed use within last 3 months
- •Photodynamic Therapy or UVB treatments in past 3 months
- •Female Subjects: pregnant or nursing
- •History of abnormal scarring (i.e., keloids)
研究组 & 干预措施
4% Imipramine Cream on UVB-Treated Areas
- 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back.
- 2g of base cream will be applied to the UVB-treated areas on volar forearm and back.
- No cream will be applied to a UVB-treated area on the back
干预措施: 4% Imipramine Cream (Drug)
4% Imipramine Cream on UVB-Treated Areas
- 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back.
- 2g of base cream will be applied to the UVB-treated areas on volar forearm and back.
- No cream will be applied to a UVB-treated area on the back
干预措施: Base Cream (Drug)
结局指标
主要结局
Change in microvesicle particle levels from baseline in clinically photosensitive subjects
时间窗: 4 Hours
This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Change in skin erythema from baseline on topical imipramine treated skin
时间窗: 24 Hours
This will be measured with a mexameter at 24 hours.
Change in microvesicle particle levels from baseline post topical imipramine application
时间窗: 4 Hours
This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
次要结局
未报告次要终点