Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Sponsor
Integrative Skin Science and Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06144541
Collaborator
(none)
500
1
5.3
93.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey administration for Fitzpatrick skin type
  • Device: Measurement of ITA based on SkinColorCatch instrument

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type
Actual Study Start Date :
Nov 21, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
General public

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

Other: Survey administration for Fitzpatrick skin type
Survey administration for Fitzpatrick skin type

Device: Measurement of ITA based on SkinColorCatch instrument
Measurement of ITA based on SkinColorCatch instrument

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrative Skin Science & Research Sacramento California United States 95815

Sponsors and Collaborators

  • Integrative Skin Science and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Integrative Skin Science and Research
ClinicalTrials.gov Identifier:
NCT06144541
Other Study ID Numbers:
  • i23-09_Fitz_Skin
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2023