Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

NCT ID: NCT06144541

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-21

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Skin Pigment

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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General public

This survey and ITA measurements will be performed among the general public

Survey administration for Fitzpatrick skin type

Intervention Type OTHER

Survey administration for Fitzpatrick skin type

Measurement of ITA based on SkinColorCatch instrument

Intervention Type DEVICE

Measurement of ITA based on SkinColorCatch instrument

Interventions

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Survey administration for Fitzpatrick skin type

Survey administration for Fitzpatrick skin type

Intervention Type OTHER

Measurement of ITA based on SkinColorCatch instrument

Measurement of ITA based on SkinColorCatch instrument

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Integrative Skin Science & Research

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Raja Sivamani, MD

Role: CONTACT

916-524-1216

Facility Contacts

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Raja Sivamani, MD MS AP

Role: primary

Other Identifiers

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i23-09_Fitz_Skin

Identifier Type: -

Identifier Source: org_study_id