Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07091604

An Observational Study to Assess Objective Skin Pigmentation Variation.

Led by Leiden University Medical Center · Updated on 2025-08-01

600

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

An Observational Study to Assess Objective Skin Pigmentation Variation.

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to understand oral and written Dutch or English
Not Eligible

You will not qualify if you...

  • Extensive tattoos covering more than 50% of the total body area
  • Recent extensive sun exposure such as 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 patients: extensive skin lesions covering more than 50% of the total body area

AI-Screening

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, Leiden, Netherlands, 2333 ZG

Actively Recruiting

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Research Team

D

Deepak M.W. Balak

CONTACT

L

Lotte J. van den Oord

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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