A Pilot Study of Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Skin elasticity measurement of participant's scars
研究概览
简要总结
The primary objective of Part A is to compare the change in elasticity measurements at baseline and at 3 months between subjects who have had a resurfacing or tightening procedure and those who have not. The secondary objective for Part A is to develop baseline elasticity scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and V-VI. The primary objective of Part B is to compare the age of the scar and surrounding tissue with the elasticity measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18-65 years of age
- •Subject scheduled to have resurfacing or tightening procedure done as Standard of Care (Arm 1, 25 subjects).
- •The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
- •Subject is 18 and over
- •Subject has a linear surgical scar that is > 2cm.
- •The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
排除标准
- •Part A, Group 1:
- •Subject is planning on having a cosmetic procedure done to their face during the 3 months they are participating in the study (Arm 2, 25 subjects).
- •Parts A and B:
- •Under 18 years of age
- •Pregnancy or Lactation
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects with mental illness
结局指标
主要结局
Skin elasticity measurement of participant's scars
时间窗: up to 3 months
Difference in skin elasticity measurements will be compared between subjects of varying ages at different anatomical sites: scarred sites, forehead, cheeks, mandible, and inner arm.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University