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Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06144541
Enrollment
500
Registered
2023-11-22
Start date
2023-11-21
Completion date
2024-05-31
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Pigment

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.

Interventions

OTHERSurvey administration for Fitzpatrick skin type

Survey administration for Fitzpatrick skin type

DEVICEMeasurement of ITA based on SkinColorCatch instrument

Measurement of ITA based on SkinColorCatch instrument

Sponsors

Integrative Skin Science and Research
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin typeOne time - collected for up to 1 year for the entire studyCorrelation 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

MeasureTime frameDescription
Assess Fitzpatrick Skin type based on validated questionnaireOne time - collected for up to 1 year for the entire studyQuestionnaire about sun sensitivity and tanning will be administered to calculate the Fitzpatrick skin types
Sun protection habit useOne time - collected for up to 1 year for the entire studyQuantification of sun protection habits based on survey question asking their typical use of sun protection

Countries

United States

Contacts

Primary ContactRaja Sivamani, MD
raja.sivamani@integrativeskinresearch.com916-524-1216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026