Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

Erythema Clinical Trial

— Melanin Index  

Official title:

A Prospective Study of Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124513
• Other study ID #: JR-STU27549
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: March 17, 2015
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Erythema

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No