Photodynamic Therapy and Microvesicles
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.
研究概览
简要总结
This study is designed to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and ultraviolet B radiation (UVB) on platelet-activating factor (PAF) and MVP production have long been part of the PI's research experience. To test this, the investigator plans to enroll up to enroll up to 12 male subjects whom are aged 21 to age 45. These subjects will be treated with topical 5-aminolevulinic acid gel (Ameluz) to small areas of forearm followed by treatment with blue light. The areas will then be treated with either 4% imipramine cream or cream base as control. Four hours later, the redness of the areas will be measured using a mexameter and MVPs measured in skin biopsies taken from PDT-treated skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male adult subjects age 21 to age 45
- •Skin type must be "fair", Fitzpatrick type I or II
- •Able to understand/complete informed/consent
- •Have access to stable transportation
排除标准
- •Underlying diseases that could affect wound healing (e.g., diabetes mellitus)
- •Taking medications that are known photosensitizers (e.g., doxycycline) or anti- inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- •Have a history of abnormal scarring (e.g., keloids)
- •Taking vitamin C or E supplements for past month
- •Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
- •Utilizing topical anti-inflammatory or systemic agents (eg, prednisone)
- •Tanning bed use within last 3 months
- •PDT or UVB treatments in past 3 months
研究组 & 干预措施
4% Imipramine Cream on Upper Forearm Site
Base cream will be applied to the lower forearm site.
干预措施: Photodynamic Therapy (Device)
4% Imipramine Cream on Upper Forearm Site
Base cream will be applied to the lower forearm site.
干预措施: 4% Imipramine (Drug)
4% Imipramine Cream on Upper Forearm Site
Base cream will be applied to the lower forearm site.
干预措施: Base Cream (Drug)
4% Imipramine Cream on Lower Forearm Site
Base cream will be applied to the upper forearm site.
干预措施: Photodynamic Therapy (Device)
4% Imipramine Cream on Lower Forearm Site
Base cream will be applied to the upper forearm site.
干预措施: 4% Imipramine (Drug)
4% Imipramine Cream on Lower Forearm Site
Base cream will be applied to the upper forearm site.
干预措施: Base Cream (Drug)
结局指标
主要结局
Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.
时间窗: Day 0
PI will assess change from baseline using three 5 mm punch biopsies.
Change in Microvesicle Particle Levels From Baseline with 4% Imipramine Cream Treatment.
时间窗: Day 2
PI will assess change from baseline using three 5 mm punch biopsies.
次要结局
- Change in Erythema From Baseline Due to Photodynamic Therapy(Day 2)
- Change in Skin Pain From Baseline Due to Photodynamic Therapy(Day 2)
- Change in Itch From Baseline Due to Photodynamic Therapy(Day 2)