Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

NCT ID: NCT01124513

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Digital Camera

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

Group Type: ACTIVE_COMPARATOR

Induced Erythema

Intervention Type: 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.

Spectrophotometer

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

Group Type: ACTIVE_COMPARATOR

Induced Erythema

Intervention Type: 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.

Videodermoscopy

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

Group Type: ACTIVE_COMPARATOR

Induced Erythema

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

June Robinson

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

June K Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Dennis P West, PhD

Role: STUDY_DIRECTOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24048361 (View on PubMed)

Other Identifiers

JR-STU27549

Identifier Type: -

Identifier Source: org_study_id