Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI (Melanin Index)

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.

Study Overview

• Status: Completed
• Conditions: Erythema
• Intervention / Treatment: Procedure: Induced Erythema

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital Camera; Digital camera images will be taken of a a 2cm^2 area of sun protected skin.	Procedure: Induced Erythema; Study personnel will induce erythema by sequentially applying ice for approximately 2 minutes to the 2 cm^2 target region of the upper volar arm. This erythema is a reaction to the vasoconstriction caused by skin cooling. The vasoconstriction is visually monitored to determine the onset of the vascular dilation that occurs after cessation of cooling. Images with the Digital Camera, Spectrophotometer and Videodermoscope are re-taken.
Active Comparator: Spectrophotometer; The probe of the protable reflectance spectrophotometer is lightly applied to the sufance of the skin and a reading is taken.	Procedure: Induced Erythema; Study personnel will induce erythema by sequentially applying ice for approximately 2 minutes to the 2 cm^2 target region of the upper volar arm. This erythema is a reaction to the vasoconstriction caused by skin cooling. The vasoconstriction is visually monitored to determine the onset of the vascular dilation that occurs after cessation of cooling. Images with the Digital Camera, Spectrophotometer and Videodermoscope are re-taken.
Active Comparator: Videodermoscopy; The instrument is put in contact with sun protected skin and an image is taken of a 2 cm^2 area.	Procedure: Induced Erythema; Study personnel will induce erythema by sequentially applying ice for approximately 2 minutes to the 2 cm^2 target region of the upper volar arm. This erythema is a reaction to the vasoconstriction caused by skin cooling. The vasoconstriction is visually monitored to determine the onset of the vascular dilation that occurs after cessation of cooling. Images with the Digital Camera, Spectrophotometer and Videodermoscope are re-taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Melanin Index	Compare the MI obtained by the digital camera, videodermoscope and spectrophotmetry between the usual conditions and after the induction of erythema.	2 minutes
Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type	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.	Up to 10 minutes
Difference in Time to Complete each of the 3 methods (digital camera, videodermoscope and spectrophotometer)	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.	Up to 10 minutes
Desirability and Relevance of Videodermoscopy Image	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.	Up to 10 minutes

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Study Director: Dennis P West, PhD, Northwestern University

Publications and helpful links

General Publications

• Eilers S, Bach DQ, Gaber R, Blatt H, Guevara Y, Nitsche K, Kundu RV, Robinson JK. Accuracy of self-report in assessing Fitzpatrick skin phototypes I through VI. JAMA Dermatol. 2013 Nov;149(11):1289-94. doi: 10.1001/jamadermatol.2013.6101.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 17, 2010

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Melanin Index; Spectrophotometry; Fitzpatrick Skin Phototype; Videodermoscopy
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: JR-STU27549