Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Recruiting

• Conditions: Skin Pigment
• Interventions: Other: Survey administration for Fitzpatrick skin type; Device: Measurement of ITA based on SkinColorCatch instrument

• Registration Number: NCT06144541
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-10-12
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-16
• Study Start: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General public	Measurement of ITA based on SkinColorCatch instrument	This survey and ITA measurements will be performed among the general public
General public	Survey administration for Fitzpatrick skin type	This survey and ITA measurements will be performed among the general public

Primary Outcome Measures

Name	Time	Method
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type	One time - collected for up to 1 year for the entire study	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science & Research; 🇺🇸 Sacramento, California, United States