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

Primary Purpose

Erythema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Induced Erythema
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Erythema focused on measuring Melanin Index, Fitzpatrick Skin Phototype, Videodermoscopy, Spectrophotometry

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Digital Camera

Spectrophotometer

Videodermoscopy

Arm Description

Digital camera images will be taken of a a 2cm^2 area of sun protected skin.

The probe of the protable reflectance spectrophotometer is lightly applied to the sufance of the skin and a reading is taken.

The instrument is put in contact with sun protected skin and an image is taken of a 2 cm^2 area.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2010
Last Updated
March 17, 2015
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01124513
Brief Title
Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
Acronym
Melanin Index
Official Title
A Prospective Study of Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema
Keywords
Melanin Index, Fitzpatrick Skin Phototype, Videodermoscopy, Spectrophotometry

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Camera
Arm Type
Active Comparator
Arm Description
Digital camera images will be taken of a a 2cm^2 area of sun protected skin.
Arm Title
Spectrophotometer
Arm Type
Active Comparator
Arm Description
The probe of the protable reflectance spectrophotometer is lightly applied to the sufance of the skin and a reading is taken.
Arm Title
Videodermoscopy
Arm Type
Active Comparator
Arm Description
The instrument is put in contact with sun protected skin and an image is taken of a 2 cm^2 area.
Intervention Type
Procedure
Intervention Name(s)
Induced Erythema
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Melanin Index
Description
Compare the MI obtained by the digital camera, videodermoscope and spectrophotmetry between the usual conditions and after the induction of erythema.
Time Frame
2 minutes
Title
Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type
Description
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.
Time Frame
Up to 10 minutes
Title
Difference in Time to Complete each of the 3 methods (digital camera, videodermoscope and spectrophotometer)
Description
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.
Time Frame
Up to 10 minutes
Title
Desirability and Relevance of Videodermoscopy Image
Description
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.
Time Frame
Up to 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June K Robinson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis P West, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24048361
Citation
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.
Results Reference
result

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Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

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