Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01124513
First received: May 10, 2010
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Erythema
Procedure: Induced Erythema

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Prospective Study of Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Melanin Index [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    Compare the MI obtained by the digital camera, videodermoscope and spectrophotmetry between the usual conditions and after the induction of erythema.

  • Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 315
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124513

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: June K Robinson, MD Northwestern University
Study Director: Dennis P West, PhD Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: June Robinson, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01124513     History of Changes
Other Study ID Numbers: JR-STU27549
Study First Received: May 10, 2010
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Melanin Index
Fitzpatrick Skin Phototype
Videodermoscopy
Spectrophotometry

Additional relevant MeSH terms:
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014