Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

NCT06144541 | Unknown

• 1 other identifier: i23-09_Fitz_Skin
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Pigment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assess Fitzpatrick Skin type based on validated questionnaire

  One time - collected for up to 1 year for the entire study

• Sun protection habit use

  One time - collected for up to 1 year for the entire study

Study Arms (1)

General public

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

Other: Survey administration for Fitzpatrick skin type; Device: Measurement of ITA based on SkinColorCatch instrument

Interventions

Survey administration for Fitzpatrick skin type OTHER

Survey administration for Fitzpatrick skin type

General public

Measurement of ITA based on SkinColorCatch instrument DEVICE

Measurement of ITA based on SkinColorCatch instrument

General public

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead

Study Sites (1)

Integrative Skin Science & Research

Sacramento, California, 95815, United States

RECRUITING

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Raja Sivamani, MD

CONTACT

916-524-1216; raja.sivamani@integrativeskinresearch.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 22, 2023
• Study Start: November 21, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)