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临床试验/NCT01124513
NCT01124513已完成不适用

A Prospective Study of Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

Northwestern University2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
270
试验地点
2
主要终点
Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type

研究概览

简要总结

The "gold standard" method of assessing skin pigmentation is spectrophotometry; however, even as early as 1961 the potential for confounding by dilatation of blood vessels was recognized. (Monash 1961) Manual compression was used to express the blood from the field being measured. The red reflectance captured by reflectance spectrophotometer introduced an uncontrollable variable when measuring the tanning /pigmentation response of skin tone/color. Room temperature induced increased or decreased blood flow through the skin, which altered the findings by spectrophotometer. Other potentially confounding variables that changed blood flow were: recent exercise, and the flushing/blushing for emotional reasons. Since these conditions were difficult to reliably control on the sun exposed extremities, spectrophotometry was not a practical method to assess change in melanin over time as an outcome measure for efficacy of sun protection.

Digital imaging with videodermatoscopy utilizing a portable device that is supported by a laptop computer, provides a high resolution digital image for analysis. (EasyScan) As described by Yamamoto et al (2008), applying the Image J freeware to quantify the pigmentation in the digital image holds promise as a practical objective method to reliably assess skin tones based on the melanin content in a non invasive manner. With standardization, the software and hardware may quantify the constitutive pigment in the sun protected skin as the melanin index.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years old
  • fluent in English
  • able to complete the study procedures including answering questionnairs
  • willing to apply ice to left upper inner arm
  • willing to have digital photos, dermatoscopic photos and spectrophometry readings taken of left upper inner arm

排除标准

  • have a history of vitiligo or currently has vitiligo
  • use self-tanning products or tan accelerators ont he left upper inner arm int he 4 weeks prior to enrollment
  • history of cold urticaria or conenctive tissue disease such as scleroderma

结局指标

主要结局

Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type

时间窗: Up to 10 minutes

Correlate the melanin index under usual conditions by each of the 3 methods (digital camera, videodermoscope and spectrophotometry) with the Fitzpatrick skin phyototype as determined by the patients' responses to standard questions, and the dermatologist's determination of skin type.

Difference in Time to Complete each of the 3 methods (digital camera, videodermoscope and spectrophotometer)

时间窗: Up to 10 minutes

Compare the time of testing (duration of each test for thes ubject, time spent by the research assistant administering the test) between the digitical camera, videodermoscope and spectrophotometer.

Desirability and Relevance of Videodermoscopy Image

时间窗: Up to 10 minutes

Assess desirability and relevance of the image obtained by videodermoscopy to the subject especially with reference to the subject's assessment of their risk of sunburning.

Change in Melanin Index

时间窗: 2 minutes

Compare the MI obtained by the digital camera, videodermoscope and spectrophotmetry between the usual conditions and after the induction of erythema.

次要结局

未报告次要终点

研究者

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

June Robinson

Professor of Dermatology

Northwestern University

研究点 (2)

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