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Идёт набор NCT07091604

An Observational Study to Assess Objective Skin Pigmentation Variation.

— Наблюдательное Skin Diseases Healthy Skin

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Skin Diseases, Healthy Skin. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
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Официальное название

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

Обзор

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.

Первичные конечные точки

  • Melanin index [Срок оценки: At baseline study visit (single time point)]
Вторичные конечные точки (11)
  • Fitzpatrick skin type [Срок оценки: At baseline study visit (single time point)]
  • Age [Срок оценки: At baseline study visit (single time point)]
  • Ethnicity [Срок оценки: At baseline study visit (single time point)]
  • Line-Field Confocal Optical Coherence Tomography (LC-OCT) [Срок оценки: At baseline study visit (single time point)]
  • 3D Multispectral imaging [Срок оценки: At baseline study visit (single time point)]
  • Colorimetry [Срок оценки: At baseline study visit (single time point)]
  • Skin barrier function by Skin Barrier Pro [Срок оценки: At baseline study visit (single time point)]
  • VISIA [Срок оценки: At baseline study visit (single time point)]
  • Patient and Observer Scar Assessment Scale [Срок оценки: At baseline study visit (single time point)]
  • Laser speckle contrast imaging [Срок оценки: At baseline study visit (single time point)]
  • Scarletred® Vision [Срок оценки: At baseline study visit (single time point)]

Критерии участия

Inclusion Criteria:-

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Leiden University Medical Center — Leiden

Идентификаторы

NCT: NCT07091604 · NL-009794

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗