Characterization of Dyschromic Hypertrophic Scar: An Observational Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Identify Melanocyte Presence
研究概览
简要总结
Currently, there are limited prevention or treatments available for dyschromia in burn hypertrophic scars (HTSs). The limited available techniques involve transferring melanocytes from unaffected areas to the scar to adjust pigment. These techniques involve the creation of a donor site and do not utilize the cells that may already be present in scars. This study aims to confirm melanocyte presence in regions of hypo- and hyper- pigmented HTS. If melanocytes can be found in regions of hypopigmentation, these scars may be able to be treated in the future by pigmentation stimulators without the need for surgery. Additionally, if pigmentation specific molecules of interest can be found to be up-regulated in hyperpigmented scar, these may be able to be altered by a pharmacotherapy.
详细描述
Subjects with burn scars that are lighter and/or darker than their normal skin will be asked to participate in this study. It is being done to obtain more information about why some people develop scars that are different in color to their normal skin after trauma to the skin such as a burn.
Participants who wish to participate will have scar measured with a ruler, and study sites identified and photographed.
Additionally the following procedures will be done:
Non-invasive measurements: Each area of scar will have multiple non-invasive measurements done. These include:
- scar scales - subjective measures of color, itching, pain, height, etc.
- elasticity - a probe is briefly placed on top of the skin to measure its ability to stretch
- induration - a probe is briefly placed on top of the skin to measure how firm it is
- color - a skin probe in briefly placed on top of the skin to measure its color
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •18 years of age or older
- •Skin trauma resulting in a dyschromic scar
排除标准
- •Dyschromic scar dole to face, genitals, fingers, or toes
- •Known Lidocaine allergy
- •Pregnancy
- •Prisoner Status
结局指标
主要结局
Identify Melanocyte Presence
时间窗: 1 year
Confirm melanocyte presence in regions of hyper- and hypo-pigmented HTS, as well as normal skin by multiple assays including en face staining and immunofluorescent staining with melanocytes markers.
次要结局
- Characterize Pigmentation Signaling(1 year)
- Characterize melanin levels using non-invasive skin probes(1 year)