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Clinical Trials in the Netherlands / NCT07091604
Recruiting Observational

An Observational Study to Assess Objective Skin Pigmentation Variation.

NCT07091604 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Leiden University Medical Center
Phase
Observational
Started
2025-07-22
Last updated
2025-08-01

Condition(s) studied

Skin DiseasesHealthy Skin

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:- * Age ≥ 18 years * Ability to understand oral and written Dutch or English Exclusion Criteria: 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

Primary outcome measure(s)

  • Melanin index — At baseline study visit (single time point)
    Melanin index as measured by skin colorimetry and multispectral imaging.

Trial sites (1)

FacilityCityRegionStatus
Leiden University Medical Center Leiden Leiden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07091604 on ClinicalTrials.gov ↗ ← All trials in the Netherlands