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临床试验/NCT06144541
NCT06144541招募中不适用

Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Integrative Skin Science and Research1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type

时间窗: 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.

次要结局

  • Sun protection habit use(One time - collected for up to 1 year for the entire study)
  • Assess Fitzpatrick Skin type based on validated questionnaire(One time - collected for up to 1 year for the entire study)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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