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临床试验/NCT02090894
NCT02090894已完成不适用

Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin

Indiana University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2011年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers

研究概览

简要总结

The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much greater in elderly over younger individuals. The objective of the present study is to build upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects. Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets the microvasculature and stimulates collagen production while protecting the epidermis. Generally, Laser Genesis is used clinically to improve irregularities in the contour, texture, and color of the skin. Laser Genesis is also used to help treat photoaging by increasing collagen formation, suggesting that it stimulates fibroblast activity and thus possibly increases levels of protective IGF-1.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only subjects older than 65 years will be enrolled.
  • Subject's skin type must be "Fair", Fitzpatrick type I or II.

排除标准

  • Subjects who have underlying diseases that could affect wound healing (eg, diabetes mellitus)
  • on medications that are known photosensitizers,
  • or have a history of abnormal scarring (eg, keloids) will be excluded.
  • Subjects will be asked the screening questions below as part of the inclusion/exclusion criteria
  • How old are you?
  • Do you regularly use tanning beds?
  • Are you being treated with light therapy?
  • Have you had any diseases that got worse when you went in the sun?
  • Are you taking any medications that warn you to stay out of the sun?
  • Have you ever had a reaction to medications that were applied to your skin?
  • When cuts or wounds on your skin heal, are the scars abnormally large or take a long time to heal?
  • Do you have diabetes mellitus or have you ever had high blood sugar?

研究组 & 干预措施

UV Light

Experimental

干预措施: UV Light (Laser Genesis) (Device)

结局指标

主要结局

Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers

时间窗: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB

Number of double positive cells per 1000 total basal layer keratinocytes

次要结局

  • Relative Level of IGF-1 mRNA in the Skin(untreated and LaserGenesis treated, three months after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ally-Khan Somani

M.D., Ph.D.

Indiana University

研究点 (2)

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