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NCT07091604: SKIN-IMAGING

An Observational Study to Assess Objective Skin Pigmentation Variation.

Recruiting now Last updated 1 August 2025
What this trial tests

trial in Skin Diseases in 600 participants. Currently enrolling.

Timeline
22 July 2025
Primary endpoint
22 January 2027
22 January 2027

Quick facts

Lead sponsorLeiden University Medical Center
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date22 July 2025
Primary completion22 January 2027
Estimated completion22 January 2027
Sites1 location across Netherlands

Conditions studied

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with Skin Diseases or Healthy Skin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Validation of Imaging Biomarkers in Mycosis Fungoides.
    Wind SS, Beljaards ESM, Rijneveld R, Bruijnincx L, et al · · 2026 · cited 1× · PMID 41810692 · DOI 10.1111/exd.70236

Verify or expand the search:

Other recruiting trials for Skin Diseases

Currently open trials in the same condition.

Other Leiden University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07091604.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing