Recruiting

Observational StudyCorrelation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Sponsor:

Integrative Skin Science and Research

Code:

NCT06144541

Conditions

Skin Pigment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Survey administration for Fitzpatrick skin type

Measurement of ITA based on SkinColorCatch instrument

Study Details

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

Study ID

NCT06144541

Start date

Nov 21, 2023

Status verified date

Nov, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

General public

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

Interventions

Survey administration for Fitzpatrick skin type

Measurement of ITA based on SkinColorCatch instrument

Primary outcome measure

Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type [ Time Frame: One time - collected for up to 1 year for the entire study ]

Central Contacts and Locations

Central contacts

Raja Sivamani, MD

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

Locations

Integrative Skin Science & Research

Recruiting

Sacramento, California, United States, 95815

Principal Investigator:

Raja Sivamani, MD MS AP

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2023-11-28.