Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To test if localized thermal burn injury will generate more microvesicle particles over untreated skin.
研究概览
简要总结
The purpose of this study is to determine the amount of substances contained in skin known as microvesicle particles (MVP). Studies suggest these MVP are involved in many conditions such as after the thermal burn injury. These particles are typically found in skin and are evaluated by taking a portion of area with skin biopsy. The hypothesis to be tested is that people treated with a small burn injury will result in MVP levels and that this can be blocked by applying the drug amitriptyline to the area. The topical amitriptyline will be given either immediately after the burn, or at a short time afterwards (5 or 15 minutes). Skin biopsies of the areas will be taken and the study team will measure the MVPs in the skin. By utilizing these methods the study team can determine if there are differences in the numbers of MVP made following a small thermal burn injury and if this can be blocked by topical treatment with amitriptyline.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Males/Females ages 18-64
- •All skin types on Fitzpatrick Scale (Type I-VI)
- •Able to comprehend procedures and risks
- •Must be able to give informed consent
排除标准
- •Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
- •History of abnormal scarring (i.e., keloids) or poor wound healing
- •No over the counter non-steroidal anti-inflammatory agents (aspirin, acetaminophen) or antioxidant vitamins (vitamin C) in past 14 days.
- •Currently taking known photosensitizers, anti-inflammatories, other tricyclic antidepressants, or systemic agents known to be ASM inhibitors
- •Large tattoos in designated testing areas
- •Tanning bed use within last 3 months
- •UVB treatments in past 3 months
- •Pregnant or nursing
- •Known allergies to lidocaine or amitriptyline
研究组 & 干预措施
Heated Metal Bar to Skin
Five small areas on the inner forearms will be selected for treatment. Three of the areas will be treated with the heated metal bar and 10% amitriptyline is applied immediately after the burn, 5 minutes after the burn and 15 minutes after the burn. One of the selected area will be treated with the heated metal bar then a placebo will be applied. Also, placebo will be applied to one area that is not treated with the metal bar.
干预措施: Placebo (Other)
Heated Metal Bar to Skin
Five small areas on the inner forearms will be selected for treatment. Three of the areas will be treated with the heated metal bar and 10% amitriptyline is applied immediately after the burn, 5 minutes after the burn and 15 minutes after the burn. One of the selected area will be treated with the heated metal bar then a placebo will be applied. Also, placebo will be applied to one area that is not treated with the metal bar.
干预措施: Amitriptyline (Drug)
结局指标
主要结局
To test if localized thermal burn injury will generate more microvesicle particles over untreated skin.
时间窗: 2 hours after the burn injury
Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied. Vehicle will also be applied to nearby un-burned skin. Skin biopsies of burned provided vehicle and nearby unburned area with vehicle will be obtained 2 hours after localized burn injury. MVP will be measured. Briefly, the biopsies will be weighed, and treated with enzymes to break down the tissue. Following several centrifugation steps, the MVP fraction will be measured using a Nanosight instrument. The MVPs will be normalized to biopsy weight. The numbers of MVP in untreated skin will be compared to skin which underwent a thermal burn injury.
Change in the amount of microvesicle particles generated in skin from localized thermal burn injury over untreated skin.
时间窗: 2 hours after the burn injury
Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied. Vehicle will also be applied to nearby un-burned skin. Skin biopsies of burned provided vehicle and nearby unburned area with vehicle will be obtained 2 hours after localized burn injury. MVP will be measured. Briefly, the biopsies will be weighed, and treated with enzymes to break down the tissue. Following several centrifugation steps, the MVP fraction will be measured using a Nanosight instrument. The MVPs will be normalized to biopsy weight. The numbers of MVP in untreated skin will be compared to skin which underwent a thermal burn injury.
次要结局
- To test if topical 10% amitriptyline provided immediately after localized thermal burn injury will block MVP release compared to vehicle.(2 hours after the burn injury)
- The amount of MVP released after topical 10% amitriptyline is provided immediately after localized thermal burn injury compared to vehicle.(2 hours after the burn injury)