Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07091604

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

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

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Accurate assessment of skin pigmentation is important in dermatology to diagnose and manage various skin conditions. Traditional methods like visual inspection or Fitzpatrick skin type classification can be subjective, culturally biased, and often focus on lighter skin tones, which may lead to misdiagnosis or improper treatment for individuals with darker skin. This research aims to explore better, more objective ways to measure skin pigmentation using modern, non-invasive imaging technologies. The study includes two groups: healthy adults with diverse skin tones and adults with skin conditions who have active lesions being treated by a dermatologist. Researchers will use tools such as colorimetry and multispectral imaging to measure a value called the melanin index, which indicates the amount of pigment in the skin. They will compare this index across different body areas and among people with various skin tones and conditions. Participants will have a single baseline visit where several assessments will be performed, including Fitzpatrick skin type classification, Line-Field Confocal Optical Coherence Tomography, 3D multispectral imaging, colorimetry, skin barrier function testing, VISIA imaging, scar assessment scales, laser speckle contrast imaging, and Scarletred4 Vision measurements. Researchers will analyze these data to better understand skin pigmentation variation, aiming to improve diagnosis and management of skin diseases for all skin types.

CONDITIONS

Brief 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 tanning booth use or tropical stay within 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
  • For healthy volunteers: exclusion criteria same as patients except for skin lesions coverage
  • These criteria apply to both healthy volunteers and patients with skin conditions under treatment with active lesions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single time point

Participants undergo non-invasive imaging and skin assessments to measure skin pigmentation and related parameters.

1 baseline visit (in-person)

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

L

Lotte J. van den Oord

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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