Adaption of the Skin Sun Sensitivity Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University
ClinicalTrials.gov Identifier:
NCT01975038
First received: October 28, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition
Skin Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaption of the Skin Sun Sensitivity Scale for People With All Pigment Varieties

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Melanin Index by Spectrophotometry [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Participant Self-Report of Fitzpatrick Skin Type [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Subjects will be asked to respond to the standard survey questions about ease of sunburning and tanning. (Q1, 2)

  • Assessment of Ease of Freckling as a Child and Ethnicity [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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)

  • Assessment of Fitzpatrick Skin Type using the Adapted Skin Phototype Measure [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Trained personnel will review interview the subjects' response to survey items 1 and 2 and assign a SPT determined by their responses. (Q9)


Enrollment: 292
Study Start Date: October 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975038

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Study Director: Dennis P West, PhD Northwestern University
  More Information

Publications:

Responsible Party: June Robinson, Research Professor of Dermatology (MD), Northwestern University
ClinicalTrials.gov Identifier: NCT01975038     History of Changes
Other Study ID Numbers: STU00086547
Study First Received: October 28, 2013
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Melanin Index
Fitzpatrick Skin Phototype
Spectrophotometry
Skin Diseases

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014