Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

Not Applicable

Completed

• Conditions: Erythema
• Interventions: Procedure: Induced Erythema

• Registration Number: NCT01124513
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-17
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Camera	Induced Erythema	Digital camera images will be taken of a a 2cm\^2 area of sun protected skin.
Spectrophotometer	Induced Erythema	The probe of the protable reflectance spectrophotometer is lightly applied to the sufance of the skin and a reading is taken.
Videodermoscopy	Induced Erythema	The instrument is put in contact with sun protected skin and an image is taken of a 2 cm\^2 area.

Primary Outcome Measures

Name	Time	Method
Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type	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)	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	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	2 minutes	Compare the MI obtained by the digital camera, videodermoscope and spectrophotmetry between the usual conditions and after the induction of erythema.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States