Clinical trial Recruiting at 1 site Observational Ages 18 and up

Objective measurement of skin pigmentation with colorimetry and multispectral imaging

Official title: Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging

Run by Leiden University Medical Center · NCT07091604 · Data updated 2026-11-12

We will test whether non-invasive imaging (colorimetry, multispectral imaging, and line-field confocal OCT) can provide reliable, objective skin pigmentation measurements for adults with healthy skin or skin conditions.

More Skin Diseases trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorLeiden University Medical Center
Academic / other
Locations1 site (Leiden, Leiden)
StatusRecruiting
StartedJuly 22, 2025
Main results expectedJanuary 22, 2027
Study endsJanuary 22, 2027
Registry record updatedAugust 1, 2025
Trial IDNCT07091604 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with healthy skin or skin conditions who can read Dutch or English and do not have extensive tattoos or recent tanning/self-tanner use are ideal candidates.

Probably not a fit

People with extensive tattoos or skin lesions covering over 50% of the body, recent extensive sun exposure, recent use of self-tanner, minors, or those unable to consent are unlikely to be eligible or to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect objective skin pigmentation data using tools such as colorimetry, multispectral imaging, melanin index measurements, and line-field confocal optical coherence tomography. Participants include healthy volunteers and patients with skin conditions, all aged 18 or older and able to understand Dutch or English. Data will be gathered at Leiden University Medical Center and compared across skin tones and clinical presentations to explore consistent measurement approaches. Exclusion criteria include extensive tattoos or lesions covering more than half the body, recent intense sun exposure, or recent use of self-tanner.

Why it matters

Potential benefit: If successful, this could make skin tone measurement more consistent and unbiased, helping doctors diagnose and treat skin conditions more accurately across all skin tones.

How similar studies have gone: Similar imaging methods have been used successfully in research settings, but no universally accepted clinical standard for objective pigmentation measurement currently exists.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Leiden University Medical Center
    Leiden, Leiden, Netherlands
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.