Objective measurement of skin pigmentation with colorimetry and multispectral imaging
Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, Leiden) |
| Trial ID | NCT07091604 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Similar imaging methods have been used successfully in research settings, but no universally accepted clinical standard for objective pigmentation measurement currently exists.
Eligibility criteria
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 this trial is running
Leiden, Leiden
- Leiden University Medical Center — Leiden, Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: Deepak M.W. Balak
- Email: d.m.w.balak@lumc.nl
- Phone: +31715296273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.