Adaption of the Skin Sun Sensitivity Scale

July 30, 2014 updated by: June Robinson, Northwestern University

Adaption of the Skin Sun Sensitivity Scale for People With All Pigment Varieties

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.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. BACKGROUND AND RATIONALE:

    We extended the pilot study (IRB STU27549) of our objective measurement of skin pigmentation with correlation to the self-reported skin reaction to sun exposure to a larger sample with special emphasis on people with skin of color and compare the results to those obtained by spectrophotometry. We found that forty-two percent (114 of 270) of the participants' responses to the burning and tanning questions could not be classified using standard Fitzpatrick skin phototype (FST) definitions. 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.

    Fitzpatrick Skin Phototyping Skin phototyping has usually been determined subjectively by trained investigators or clinicians using sun burning and/or sun tanning responses. In addition, subject self-report of ease of sunburning and tanning is used in surveys to determine the risk of developing skin cancer. (Table 1) Responses to the Fitzpatrick Skin Phototype (SPT) questions may be unreliable due to recall bias, subjective bias by clinicians and subjects, lack of cultural sensitivity of the questions, and the subjects' use of sun protection behaviors from early childhood such that the subject may not have experienced sunburn.

    Table 1. Skin type; Erythema and Tanning Reactions to the First Summer Exposure I Always burns, never tan (painful burn at 24 hrs and no tan at 7d) II Burn easy, then develop light tan (painful burn at 24 hrs and a light tan at 7d) III Burn moderately, then develop light tan (slightly tender burn at 24 hrs, moderate tan at 7d) IV Burn minimally-rarely, then develop moderate tan (no burn at 24 hrs and a good tan at 7d) V Never burns, always develops dark tan VI Never burns, no noticeable change in appearance

    Unreliable Sunburning History A limitation of the 6 integer Roman numeral Fitzpatrick SPT was reliance upon a history of sunburn after the first exposure of the summer. For those who reside in regions that have sun exposure all year (e.g. Arizona, Florida, California), the sunburning-tanning question after the first exposure of the summer was often irrelevant. Lastly, in the 1990s people began to use sunscreens to prevent sunburns, thus, those with sun sensitive skin may never have experienced sunburn and were unable to answer the question about ease of sun burning.

    Multi-ethnic Populations There has been a tendency to group all people of a similar ethnic group into a single category of SPT, which introduces potential bias into the subjective assessment of SPT by investigators. For example, Hispanic whites are often considered "brown" and assigned to Skin Type IV (Table 2). The heterogeneity of those with multi-ethnic backgrounds makes it difficult to assess susceptibility to skin cancer on the basis of skin color, which is predominantly determined by pigments such as hemoglobin, melanin, bilirubin, and carotene.

    Skin Phototyping by Sunburning Ability. Skin Phototype Appearance Sunburning ability I Very white or freckled Always burn II White Usually burn III White to Olive Sometimes burn IV Brown Rarely burn V Dark brown Very rarely burn VI Black Never burn

    Over the last 3 decades, the Fitzpatrick SPT evolved from its original purpose of determining the amount of ultraviolet light (UVL) for treatment of psoriasis patients living in New England to become an assessment tool for skin cancer risk. As part of this evolution, the original 4 skin types (I-IV), that assessed sun reactivity with standardized questions about the ease of sun burning and tanning reactions to the first summer sun exposure, were modified by adding SPT V and VI to include those with brown and black skin.

    Our research demonstrated that the SPT modifications to include people with skin of color were neither culturally sensitive nor accurate as people of color were unable to respond to the questions about their experience with sunburn and tanning. People with skin of color did not report becoming red or pink but rather experienced "irritation" after sun exposure. In our recently reported work, we proposed a modification of the FST questions to allow people with skin of color to be able to respond (Survey questions 1and 2). We now wish to test the responses of people to these self-report questions and compare the responses with the melanin index as determined by spectrophotometry.(Survey question 9)

    Spectrophotometry The "gold standard" method of assessing skin pigmentation is reflectance spectrophotometry (RS). Pershing et al performed seminal research comparing the area under the curve obtained by RS to profile the constitutive skin color with clinicians' assessment of SPT. For skin types I-III, Pershing et al (2008) found inconsistency between clinicians' and reflectance spectrophotometric (RS) assessments of SPT. The clinicians adjusted the patients' SPT as determined by their historical sun burning and tanning response by factoring in observed hair and eye color. For example, red-haired individuals determined by RS to be SPT III were listed as SPT I by clinical dermatologists. Subjective assessment of SPT by clinicians was heavily influenced by patients' hair and eye color. The Pershing study, which accrued 125 subjects did not accrue sufficient numbers of subjects with skin of color (Skin types III-VI) to be able to report meaningful results. (I 20; II 53, III 21, IV 10, V 16, VI 5)

    It should be noted that the area under the curve obtained by RS includes the red reflectance, thus, it is does not solely represent skin pigmentation. Skin pigmentation or melanin provides photoprotection and can be calculated as melanin index, MI. (see following section on Melanin Index) Even as early as 1961, the potential for confounding of the MI obtained by RS by dilatation of superficial blood vessels was recognized. The device, Mexameter MX 18, internally corrects for the red reflectance in calculating the melanin index. The melanin index is derived from the multilayered skin model and Lambert-Beer's law.

    Significance:

    While those that are at risk to develop skin cancer have less melanin content (skin type I) than those at low risk (skin type VI), people with skin phototypes in the mid-range (III and IV) believe that their natural skin tone is protective against sunburns, thus, they fail to use sun protection. When people with skin type III and IV are exposed to more intense ultraviolet light in more southern latitudes than Chicago they are surprised by the sunburn they experience. In our proof of principle research, people with skin type III and IV, who viewed the image of their skin on the computer screen, perceived that the "color was grainy" and made the conclusion that the "holes" in their skin pigment made it possible for them to burn

    This study will further objectively measure the MI of people with skin of color. Thus, it is essential that we accrue a representative sample of people with skin of color with all ethnic groups represented over the greatest range of skin types for those self-identifying themselves as members of the group.

  2. STUDY OBJECTIVES:

Our principal objective is to correlate the melanin index under usual conditions by spectrophotometry with the adapted Fitzpatrick SPT as determined by the patients' responses to the adapted questionnaire.

Study Type

Observational

Enrollment (Actual)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melanin Index by Spectrophotometry
Time Frame: At baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Self-Report of Fitzpatrick Skin Type
Time Frame: At baseline
Subjects will be asked to respond to the standard survey questions about ease of sunburning and tanning. (Q1, 2)
At baseline
Assessment of Ease of Freckling as a Child and Ethnicity
Time Frame: At baseline
Subjects will be asked to respond to standard questions self-reporting ease of freckling as child of about 10 years old and ethnic background. (Q3,4,7)
At baseline
Assessment of Fitzpatrick Skin Type using the Adapted Skin Phototype Measure
Time Frame: At baseline
Trained personnel will review interview the subjects' response to survey items 1 and 2 and assign a SPT determined by their responses. (Q9)
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Study Director: Dennis P West, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00086547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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