Clinical trial NCT01124513: Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
Official title: A Prospective Study of Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Keywords: Melanin Index
Fitzpatrick Skin Phototype
Videodermoscopy
Spectrophotometry
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Change in Melanin Index
timeFrame: 2 minutes
measure: Change in Melanin Index for 3 methods (digital camera, videodermoscope and spectrophotmetry) vs. patient-reported skin type vs. dermatologist-determined skin type
timeFrame: Up to 10 minutes
measure: Difference in Time to Complete each of the 3 methods (digital camera, videodermoscope and spectrophotometer)
timeFrame: Up to 10 minutes
measure: Desirability and Relevance of Videodermoscopy Image
timeFrame: Up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: June K Robinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Dennis P West, PhD
role: STUDY_DIRECTOR
References:
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.