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临床试验/NCT07091604
NCT07091604招募中不适用

Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Melanin index

研究概览

简要总结

Accurate assessment of skin pigmentation is essential in dermatology for properly diagnosing and managing a wide range of skin conditions. Traditionally, skin colour has been evaluated through visual inspection or by using classifications like the Fitzpatrick skin type. However, these methods can be subjective, culturally biased, and often are centered around lighter skin tones, which may lead to misdiagnosis or inappropriate treatment for individuals with darker skin.

With advances in technology, non-invasive imaging tools such as colorimetry and multispectral imaging now offer more precise and objective ways to measure skin pigmentation. These methods can help provide consistent and unbiased information about skin tone, benefiting both clinical care and research. Despite these technological advances, there is currently no agreed-upon standard for how to measure skin pigmentation objectively in everyday clinical practice or research settings.

This study aims to explore better, more accurate ways to measure skin pigmentation using modern, non-invasive imaging technologies. Traditional methods for assessing skin colour, like visual inspection or classifying by ethnicity, are often unreliable and biased. In this study, researchers will use tools such as colorimetry and multispectral imaging to measure skin pigmentation more objectively.

The study includes two groups of participants: healthy adults and adults with skin conditions. Researchers will measure a value called the melanin index, which reflects the amount of pigment in the skin, and compare it across different areas of the body and among people with different skin tones and conditions.

The goal is to understand how skin pigmentation varies and to see if these new technologies can help doctors more accurately diagnose and manage skin diseases for people of all skin types.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years
  • Ability to understand oral and written Dutch or English

排除标准

  • For study cohort #1 (Healthy volunteers):
  • Extensive tattoos covering >50% of the total body area
  • Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks
  • Use of self-tanner products in the last 3 weeks
  • For study cohort #2 (Patients):
  • Extensive tattoos covering >50% of the total body area
  • Extensive skin lesions covering >50% of the total body area
  • Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks
  • Use of self-tanner products in the last 3 weeks

结局指标

主要结局

Melanin index

时间窗: At baseline study visit (single time point)

Melanin index as measured by skin colorimetry and multispectral imaging.

次要结局

  • Age(At baseline study visit (single time point))
  • Skin barrier function by Skin Barrier Pro(At baseline study visit (single time point))
  • VISIA(At baseline study visit (single time point))
  • Laser speckle contrast imaging(At baseline study visit (single time point))
  • 3D Multispectral imaging(At baseline study visit (single time point))
  • Ethnicity(At baseline study visit (single time point))
  • Colorimetry(At baseline study visit (single time point))
  • Patient and Observer Scar Assessment Scale(At baseline study visit (single time point))
  • Scarletred® Vision(At baseline study visit (single time point))
  • Fitzpatrick skin type(At baseline study visit (single time point))
  • Line-Field Confocal Optical Coherence Tomography (LC-OCT)(At baseline study visit (single time point))

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

dmwbalak

Principal Investigator

Leiden University Medical Center

研究点 (1)

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