Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.

Study Overview

• Status: Recruiting
• Conditions: Skin Pigment
• Intervention / Treatment: Other: Survey administration for Fitzpatrick skin type; Device: Measurement of ITA based on SkinColorCatch instrument

Detailed Description

The Fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to UV light. It is used by dermatologists to classify skin tone and assess the risk of skin cancer.

The Fitzpatrick scale encompasses six gradings, from I to VI. However, this does not include all skin tones, as there are significantly more not encompassed within the scale. The aim of this study is to incorporate objective measurements when identifying a patient's Fitzpatrick skin type.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Raja Sivamani, MD; Phone Number: 916-524-1216; Email: raja.sivamani@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Recruiting
      • Integrative Skin Science & Research
      • Contact: Raja Sivamani, MD MS AP
      • Principal Investigator: Raja Sivamani, MD MS AP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All subjects, healthy and unhealthy, are eligible to enroll. Subjects from the greater Sacramento region will be enrolled. Subjects must be at least 18 years of age.

Description

Inclusion Criteria:

• Male and females that are 18 years of age and older
• Subjects with all Fitzpatrick skin types I-VI One-third of subjects will be Fitzpatrick I or II skin types, one-third of subjects will be III or IV, and one-third will have V and VI.

Exclusion Criteria:

• Individuals who are pregnant or breastfeeding.
• Prisoners
• Adults unable to consent
• Individuals with open wounds on the nondominant upper inner arm
• Individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator
• Individuals with tattoos that cover the site on the nondominant upper inner arm
• Individuals with post-inflammatory hypopigmentation or hyperpigmentation
• Individuals with vitiligo
• Individuals who have used self-tanning products or tanning beds in the last two weeks.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General public; This survey and ITA measurements will be performed among the general public	Other: Survey administration for Fitzpatrick skin type; Survey administration for Fitzpatrick skin type; Device: Measurement of ITA based on SkinColorCatch instrument; Measurement of ITA based on SkinColorCatch instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type	Correlation of ITA by the use of SkinColorCatch (Delfin) compared to the Fitzpatrick skin scale as determined by the patients' responses to validated questionnaire. The higher the ITA, the lighter the skin. ITA skin color types are classified into six groups, from Very Light to Dark skin.	One time - collected for up to 1 year for the entire study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Fitzpatrick Skin type based on validated questionnaire	Questionnaire about sun sensitivity and tanning will be administered to calculate the Fitzpatrick skin types	One time - collected for up to 1 year for the entire study
Sun protection habit use	Quantification of sun protection habits based on survey question asking their typical use of sun protection	One time - collected for up to 1 year for the entire study

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: i23-09_Fitz_Skin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No