Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to understand oral and written Dutch or English
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here