Erythema Clinical Trial
Official title:
A Prospective Study of Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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