Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

NCT01124513 | Completed

• 1 other identifier: JR-STU27549
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythema

Keywords

Melanin Index; Fitzpatrick Skin Phototype; Videodermoscopy; Spectrophotometry

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Digital Camera

ACTIVE COMPARATOR

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

Procedure: Induced Erythema

Spectrophotometer

ACTIVE COMPARATOR

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

Procedure: Induced Erythema

Videodermoscopy

ACTIVE COMPARATOR

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

Procedure: Induced Erythema

Interventions

Induced Erythema PROCEDURE

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.

Digital Camera; Spectrophotometer; Videodermoscopy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 24048361 RESULT

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• June K Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Dennis P West, PhD

  Northwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

US (1)