NCT01975038

Brief Summary

Determining Fitzpatrick skin phototypes (FST) allows physicians to assess a person's risk of developing sunburn, and thus the need for sun protection to prevent the development of skin cancer. Reflectance spectrophotometry objectively measures the melanin index (MI) and can assist in determining the accuracy of self-reported FST compared with dermatologist-determined FST. At present, we seek to determine the accuracy of an adapted Skin Sun Sensitivity Scale for individuals of all pigmentation varieties (FST I through VI) as compared with spectrophotometric measurements assessing FST. Our principal objective is to correlate the MI under usual conditions by spectrophotometry with the adapted Fitzpatrick SPT as determined by the patients' responses to the adapted questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

October 28, 2013

Last Update Submit

July 30, 2014

Conditions

Keywords

Melanin IndexFitzpatrick Skin PhototypeSpectrophotometrySkin Diseases

Outcome Measures

Primary Outcomes (1)

  • Melanin Index by Spectrophotometry

    Spectrophotometer measurement is the wavelength of the reflected light measured in nm. It represents the area under the curve for the all wavelengths of light, thus a reading will be expressed as (192 ±30, mean ± SD).

    At baseline

Secondary Outcomes (3)

  • Participant Self-Report of Fitzpatrick Skin Type

    At baseline

  • Assessment of Ease of Freckling as a Child and Ethnicity

    At baseline

  • Assessment of Fitzpatrick Skin Type using the Adapted Skin Phototype Measure

    At baseline

Study Arms (1)

A convenience sample

The characteristics of the sample will be monitored to assure that each category of skin type (I- VI) is accrued in sufficient size to support analysis. In addition, the sample will have equal representation from 4 ethnic groups within each skin type category: African American, Asian, Hispanic, or non-Hispanic White. Participants will self-identify as being Asian, Black, Hispanic Black, Hispanic White, or non-Hispanic White.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of approximately 200 Northwestern University students, employees (faculty and staff), patients attending the dermatology clinic, and attendees of Northwestern University dermatology-related events will be selected for measurement of the melanin index with the Mexameter MX18. The characteristics of the sample will be monitored to assure that each category of skin type (I- VI) is accrued in sufficient size to support analysis. In addition, the sample will have equal representation from 4 ethnic groups within each skin type category: African American, Asian, Hispanic, or non-Hispanic White. Participants will self-identify as being Asian, Black, Hispanic Black, Hispanic White, or non-Hispanic White.

You may qualify if:

  • Are at least 18 years old
  • Are fluent in English
  • Are able to complete the study procedures including answering questionnaires
  • Are willing to have spectrophotometry readings taken of right upper inner arm

You may not qualify if:

  • Used self-tanning products or tan accelerators on the right upper inner arm in the 4 weeks prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (22)

  • Chan JL, Ehrlich A, Lawrence RC, Moshell AN, Turner ML, Kimball AB. Assessing the role of race in quantitative measures of skin pigmentation and clinical assessments of photosensitivity. J Am Acad Dermatol. 2005 Apr;52(4):609-15. doi: 10.1016/j.jaad.2004.03.051.

    PMID: 15793510BACKGROUND
  • Chung JH, Koh WS, Youn JI. Relevance of skin phototyping to a Korean population. Clin Exp Dermatol. 1994 Nov;19(6):476-8. doi: 10.1111/j.1365-2230.1994.tb01250.x.

    PMID: 7889667BACKGROUND
  • Dawson JB, Barker DJ, Ellis DJ, Grassam E, Cotterill JA, Fisher GW, Feather JW. A theoretical and experimental study of light absorption and scattering by in vivo skin. Phys Med Biol. 1980 Jul;25(4):695-709. doi: 10.1088/0031-9155/25/4/008.

    PMID: 7454759BACKGROUND
  • Diffey BL, Oliver RJ, Farr PM. A portable instrument for quantifying erythema induced by ultraviolet radiation. Br J Dermatol. 1984 Dec;111(6):663-72. doi: 10.1111/j.1365-2133.1984.tb14149.x.

    PMID: 6508999BACKGROUND
  • 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: 24048361BACKGROUND
  • Feather JW, Ellis DJ, Leslie G. A portable reflectometer for the rapid quantification of cutaneous haemoglobin and melanin. Phys Med Biol. 1988 Jun;33(6):711-22. doi: 10.1088/0031-9155/33/6/005.

    PMID: 3406055BACKGROUND
  • Fitzpatrick TB: Soleil et peau. J Med Esthet 1975, 2:33-34

    BACKGROUND
  • Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

    PMID: 3377516BACKGROUND
  • Kim M, Boone SL, West DP, Rademaker AW, Liu D, Kundu RV. Perception of skin cancer risk by those with ethnic skin. Arch Dermatol. 2009 Feb;145(2):207-8. doi: 10.1001/archdermatol.2008.566. No abstract available.

    PMID: 19221276BACKGROUND
  • Lee JH, Kim TY. Relationship between constitutive skin color and ultraviolet light sensitivity in Koreans. Photodermatol Photoimmunol Photomed. 1999 Dec;15(6):231-5. doi: 10.1111/j.1600-0781.1999.tb00095.x.

    PMID: 10599973BACKGROUND
  • Matts PJ, Dykes PJ, Marks R. The distribution of melanin in skin determined in vivo. Br J Dermatol. 2007 Apr;156(4):620-8. doi: 10.1111/j.1365-2133.2006.07706.x.

    PMID: 17493065BACKGROUND
  • Melski JW, Tanenbaum L, Parrish JA, Fitzpatrick TB, Bleich HL. Oral methoxsalen photochemotherapy for the treatment of psoriasis: a cooperative clinical trial. J Invest Dermatol. 1977 Jun;68(6):328-35. doi: 10.1111/1523-1747.ep12496022.

    PMID: 864273BACKGROUND
  • MONASH S. Skin color. A correlation of reflectance measurement and clinical appearance. Arch Dermatol. 1961 Oct;84:654-9. doi: 10.1001/archderm.1961.01580160118023. No abstract available.

    PMID: 14475328BACKGROUND
  • National Institutes of Health. Strategic Research Plan to Reduce and Ultimately Eliminate Health Disparities Volume 1. Years 2002-2006 U.S. Department of Health and Human Services 2002.

    BACKGROUND
  • Park SB, Suh DH, Youn JI. Reliability of self-assessment in determining skin phototype for Korean brown skin. Photodermatol Photoimmunol Photomed. 1998 Oct-Dec;14(5-6):160-3. doi: 10.1111/j.1600-0781.1998.tb00035.x.

    PMID: 9826886BACKGROUND
  • Pershing LK, Tirumala VP, Nelson JL, Corlett JL, Lin AG, Meyer LJ, Leachman SA. Reflectance spectrophotometer: the dermatologists' sphygmomanometer for skin phototyping? J Invest Dermatol. 2008 Jul;128(7):1633-40. doi: 10.1038/sj.jid.5701238. Epub 2008 Jan 17.

    PMID: 18200057BACKGROUND
  • Robinson JK, Joshi KM, Ortiz S, Kundu RV. Melanoma knowledge, perception, and awareness in ethnic minorities in Chicago: recommendations regarding education. Psychooncology. 2011 Mar;20(3):313-20. doi: 10.1002/pon.1736.

    PMID: 20878831BACKGROUND
  • Rubegni P, Cevenini G, Flori ML, Fimiani M, Stanghellini E, Molinu A, Barbini P, Andreassi L. Relationship between skin color and sun exposure history: a statistical classification approach. Photochem Photobiol. 1997 Feb;65(2):347-51. doi: 10.1111/j.1751-1097.1997.tb08569.x.

    PMID: 9066310BACKGROUND
  • Shono S, Imura M, Ota M, Ono S, Toda K. The relationship of skin color, UVB-induced erythema, and melanogenesis. J Invest Dermatol. 1985 Apr;84(4):265-7. doi: 10.1111/1523-1747.ep12265342.

    PMID: 3981038BACKGROUND
  • Stanford DG, Georgouras KE, Sullivan EA, Greenoak GE. Skin phototyping in Asian Australians. Australas J Dermatol. 1996 May;37 Suppl 1:S36-8. doi: 10.1111/j.1440-0960.1996.tb01078.x.

    PMID: 8713010BACKGROUND
  • Stern RS, Momtaz K. Skin typing for assessment of skin cancer risk and acute response to UV-B and oral methoxsalen photochemotherapy. Arch Dermatol. 1984 Jul;120(7):869-73.

    PMID: 6732259BACKGROUND
  • Takiwaki H, Shirai S, Kanno Y, Watanabe Y, Arase S. Quantification of erythema and pigmentation using a videomicroscope and a computer. Br J Dermatol. 1994 Jul;131(1):85-92. doi: 10.1111/j.1365-2133.1994.tb08462.x.

    PMID: 8043425BACKGROUND

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Dennis P West, PhD

    Northwestern University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor of Dermatology (MD)

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 4, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 1, 2014

Record last verified: 2014-07

Locations