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Skin DiseasesNCT01975038

Adaption of the Skin Sun Sensitivity Scale

An observational study of Skin Diseases, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Skin Diseases
How many people
292 participants
Where
1 siteUnited States
Study dates
Oct 2013to Jul 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Skin Diseases
Keywords
Melanin Index, Fitzpatrick Skin Phototype, Spectrophotometry, Skin Diseases
Medical subject headings
Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01975038
Study groupRoleWhat they receive
A convenience sampleThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At baseline

Secondary outcomes (3)
  1. Participant Self-Report of Fitzpatrick Skin Type

    Subjects will be asked to respond to the standard survey questions about ease of sunburning and tanning. (Q1, 2)

    Measured: At baseline

  2. Assessment of Ease of Freckling as a Child and Ethnicity

    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)

    Measured: At baseline

  3. Assessment of Fitzpatrick Skin Type using the Adapted Skin Phototype Measure

    Trained personnel will review interview the subjects' response to survey items 1 and 2 and assign a SPT determined by their responses. (Q9)

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01975038
Sponsor's protocol ID
STU00086547
Status last verified
Jul 2014
First submitted
28 Oct 2013
Last updated
1 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15793510
  • 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.

    PubMed 7889667
  • 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.

    PubMed 7454759
  • 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.

    PubMed 6508999
  • 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.

    PubMed 24048361
  • 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.

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

  • 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.

    PubMed 3377516
  • 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.

    PubMed 19221276
  • 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.

    PubMed 10599973
  • 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.

    PubMed 17493065
  • 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.

    PubMed 864273
  • 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.

    PubMed 14475328
  • 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.

  • 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.

    PubMed 9826886

Questions about this trial

What is this clinical trial studying?

An observational study of Skin Diseases, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Melanin Index by Spectrophotometry (time frame: At baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01975038, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.

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