Skin DiseasesSKIN-IMAGINGNCT07091604
An Observational Study to Assess Objective Skin Pigmentation Variation.
An observational study of Skin Diseases and Healthy Skin, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Healthy Skin
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2025to 22 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For study cohort #1 (healthy volunteers): adult subjects will be recruited at multiple locations to ensure a diverse study population reflecting the full spectrum of skin colour types. Firstly, volunteers will be recruited using flyers at the campus of Leiden University. Along with that, partners of patients visiting the outpatient dermatology clinic of the LUMC. Lastly, subjects will be asked to partake in the study at public spaces (e.g. museums, festivals) that have given consent for this. Thus, subjects will be recruited in person by researchers at the aforementioned sites, through physical advertisements and digital advertisements. For study cohort #2 (patients with any skin disease): adult subjects with be recruited at the outpatient dermatology clinic of the LUMC and the affiliated hospitals of the CONNECTED (Clinical Network for Trials in Dermatology) in the Randstad region (e.g., The Hague, Zoetermeer, and Amsterdam).
Who may be able to join
- Age ≥ 18 years
- Ability to understand oral and written Dutch or English
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, Leiden, 2333 ZG
Deepak M.W. Balak, +31715296273, d.m.w.balak@lumc.nl
About this study
Official title: Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging
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.
Read more
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.
- Conditions
- Skin Diseases, Healthy Skin
- Keywords
- Skin pigmentation, Melanin index, Colorimetry, Multispectral imaging, Line-Field Confocal Optical Coherence Tomography, Skin parameters, Skin colour, Skin color, Etnicity, TEWL, Erythema index, Non-invasieve measurement, Skin Disease, Skin of Colour, Laser speckle contrast imaging
- Medical subject headings
- Skin Diseases, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers with diverse skin tones | |
| Patients | Any patient with a skin condition under treatment by a dermatologist with active lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanin index
Melanin index as measured by skin colorimetry and multispectral imaging.
Measured: At baseline study visit (single time point)
Secondary outcomes (11)
Fitzpatrick skin type
Self-questionnaire and assessed by dermatologist
Measured: At baseline study visit (single time point)
Age
Measured: At baseline study visit (single time point)
Ethnicity
Self-reported
Measured: At baseline study visit (single time point)
Line-Field Confocal Optical Coherence Tomography (LC-OCT)
LC-OCT is a non-invasive optical imaging technique based on a combination of the optical principles of optical coherence tomography and reflectance confocal microscopy with line-field illumination, which can generate cell-resolved images of the skin, in vivo, in vertical section, horizontal section and in three dimensions.
Measured: At baseline study visit (single time point)
3D Multispectral imaging
The redness, melanin and superficial morphology of (non-)lesional skin sites and healthy skin will be determined using a 3D multispectral imaging system.
Measured: At baseline study visit (single time point)
Colorimetry
The melanin, redness and surface characteristics of (non-)lesional and healthy skin will be assessed using a colorimetry device that quantitatively measures skin color parameters, including melanin, based on reflected light.
Measured: At baseline study visit (single time point)
Skin barrier function by Skin Barrier Pro
The barrier status by trans epidermal water loss of (non-)lesional skin and healthy skin will be determined using Skin Barrier Pro
Measured: At baseline study visit (single time point)
VISIA
VISIA is a non-invasive imaging system designed for in vivo analysis of facial skin, utilizing multi-spectral imaging and digital analysis to assess various skin features, including pigmentation, porphyrins, texture, and wrinkles. The system captures standardized, high-resolution images under different lighting conditions (including cross-polarized and UV light), allowing for both surface and subsurface visualization of the skin. It provides quantitative and comparative assessments of skin health and damage, supporting both clinical evaluation and cosmetic or dermatological research.
Measured: At baseline study visit (single time point)
Patient and Observer Scar Assessment Scale
POSAS is a validated scar assessment tool that combines both patient-reported outcomes and clinical evaluation to provide a comprehensive assessment of scar quality. It consists of two complementary parts: the Observer Scale, completed by a clinician, which evaluates vascularity, pigmentation, thickness, relief, pliability, and surface area; and the Patient Scale, completed by the individual, which captures subjective symptoms such as pain, itching, and overall opinion of the scar. POSAS enables standardized, semi-quantitative scoring of scars, facilitating both clinical monitoring and research on scar treatment outcomes.
Measured: At baseline study visit (single time point)
Laser speckle contrast imaging
Laser speckle contrast imaging (LSCI) is a non-invasive optical imaging technique used to assess microvascular blood flow in vivo by analyzing the speckle pattern produced when coherent laser light is scattered by moving red blood cells. The resulting speckle contrast is inversely related to the velocity of blood flow, enabling real-time, high-resolution visualization of perfusion over large skin areas without the need for contrast agents. LSCI is particularly suited for dynamic monitoring of vascular responses in dermatology, wound healing, and inflammatory skin conditions.
Measured: At baseline study visit (single time point)
Scarletred® Vision
Scarletred® Vision is a digital, non-invasive skin imaging and analysis platform that enables objective and standardized quantification of skin conditions over time using smartphone-based photography combined with a calibrated color patch and proprietary software. The system captures high-resolution images under controlled lighting conditions and applies automated analysis algorithms to quantify parameters such as erythema, pigmentation, and lesion area. By providing reproducible, color-calibrated data, Scarletred® Vision supports longitudinal skin monitoring in clinical trials and dermatological research, including evaluation of treatment effects in inflammatory and pigmentary disorders.
Measured: At baseline study visit (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start22 Jul 2025 (estimated)
- Primary completion22 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dmwbalak, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091604
- Sponsor's protocol ID
- NL-009794
- Acronym
- SKIN-IMAGING
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging
- ClinicalTrials.gov ID
- NCT07091604
- Acronym / sponsor ID
- SKIN-IMAGING / NL-009794
- Conditions
- Skin Diseases, Healthy Skin
- Keywords
- Skin pigmentation, Melanin index, Colorimetry, Multispectral imaging, Line-Field Confocal Optical Coherence Tomography, Skin parameters, Skin colour, Skin color
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2025 (estimated)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Healthy volunteers with diverse skin tones |
| Patients | – | –Any patient with a skin condition under treatment by a dermatologist with active lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For study cohort #1 (healthy volunteers): adult subjects will be recruited at multiple locations to ensure a diverse study population reflecting the full spectrum of skin colour types. Firstly, volunteers will be recruited using flyers at the campus of Leiden University. Along with that, partners of patients visiting the outpatient dermatology clinic of the LUMC. Lastly, subjects will be asked to partake in the study at public spaces (e.g. museums, festivals) that have given consent for this. Thus, subjects will be recruited in person by researchers at the aforementioned sites, through physical advertisements and digital advertisements. For study cohort #2 (patients with any skin disease): adult subjects with be recruited at the outpatient dermatology clinic of the LUMC and the affiliated hospitals of the CONNECTED (Clinical Network for Trials in Dermatology) in the Randstad region (e.g., The Hague, Zoetermeer, and Amsterdam).
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Ability to understand oral and written Dutch or English
Key exclusion criteria (9 listed)
- 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
- Extensive tattoos covering >50% of the total body area
- Extensive skin lesions covering >50% of the total body area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Melanin index
Time frame: At baseline study visit (single time point)
Melanin index as measured by skin colorimetry and multispectral imaging.
11 secondary outcomes
Fitzpatrick skin type
Time frame: At baseline study visit (single time point)
Age
Time frame: At baseline study visit (single time point)
Ethnicity
Time frame: At baseline study visit (single time point)
Line-Field Confocal Optical Coherence Tomography (LC-OCT)
Time frame: At baseline study visit (single time point)
3D Multispectral imaging
Time frame: At baseline study visit (single time point)
Colorimetry
Time frame: At baseline study visit (single time point)
Skin barrier function by Skin Barrier Pro
Time frame: At baseline study visit (single time point)
VISIA
Time frame: At baseline study visit (single time point)
Patient and Observer Scar Assessment Scale
Time frame: At baseline study visit (single time point)
Laser speckle contrast imaging
Time frame: At baseline study visit (single time point)
Scarletred® Vision
Time frame: At baseline study visit (single time point)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases and Healthy Skin, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepak M.W. Balak (+31715296273, d.m.w.balak@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanin index (time frame: At baseline study visit (single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.