VitiligoNCT07846969
Assessment of Vitiligo Lesions Using Polarized Dermoscopy, Sub-Ultraviolet Reflectance Dermoscopy, and Ultraviolet Dermoscopy
An observational study of Vitiligo, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn how different close-up skin imaging methods show vitiligo spots in adults with vitiligo. The study will look at skin changes that may be related to whether a vitiligo spot is active, stable, or gaining color again. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with clinically diagnosed vitiligo who attend the dermatology outpatient clinic and have at least one clinically suitable non-genital vitiligo lesion for dermoscopic imaging.
Who may be able to join
- Adults aged 18 years or older
- Clinical diagnosis of vitiligo
- Presence of at least one clinically suitable non-genital vitiligo lesion for dermoscopic imaging
- Ability and willingness to provide written informed consent
Who cannot join
- Uncertain clinical diagnosis of vitiligo or presence of another hypopigmented or depigmented disorder that may interfere with lesion evaluation
- Absence of any clinically suitable non-genital vitiligo lesion for imaging
- Inability to cooperate with the imaging procedure
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Istanbul Training and Research Hospital
Istanbul
About this study
Official title: Evaluation of Morphological Findings Related to Activity, Stability, and Repigmentation in Vitiligo Lesions Using Polarized Dermoscopy, Sub-Ultraviolet Reflectance Dermoscopy, and Ultraviolet Fluorescence Dermoscopy: A Cross-Sectional Observational Imaging Study
The goal of this observational study is to learn how different close-up skin imaging methods show vitiligo spots in adults with vitiligo. The study will look at skin changes that may be related to whether a vitiligo spot is active, stable, or gaining color again.
The main question it aims to answer is: Can special light-based imaging methods show useful details of vitiligo spots differently than regular polarized dermoscopy?
Read more
Participants will have vitiligo spots photographed during one study visit. Researchers will take images using polarized dermoscopy, sub-ultraviolet reflectance imaging, and ultraviolet fluorescence dermoscopy. Dermatologists will later review the coded images and score how clearly selected skin features can be seen.
The study will not change participants' treatment. It will not include blood tests, biopsy, injections, or any other invasive procedure.
Read the detailed description
This is a single-center, cross-sectional observational imaging study in patients with clinically diagnosed vitiligo.
During a single study visit, demographic and clinical information will be recorded, including disease duration, recent disease course, current treatment status, and patient-reported changes in selected lesions. One to three clinically suitable vitiligo lesions will be included in the main assessment dataset for each participant. Genital lesions will not be evaluated due to practical imaging limitations, hygiene considerations, and participant comfort.
Each selected lesion will be imaged using the Casio DZ-D100-AEA device, which allows simultaneous acquisition of digital contact polarized dermoscopy, digital contact non-polarized dermoscopy, and sub-ultraviolet reflectance dermoscopy images from the same lesion area with a single image capture. This approach is intended to improve within-lesion comparability between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy. Non-polarized images will be obtained as an automatic device output but will not be included in the routine analysis. Ultraviolet fluorescence dermoscopy images will be obtained from the same selected lesion using the DermLite DL5 handheld ultraviolet dermoscope with a smartphone adapter.
For each participant, one lesion will be designated as the index lesion for the primary analysis. If available, the second and third lesions in the main assessment dataset may be used for secondary and exploratory analyses. In participants with more than three imaged lesions, additional lesion images beyond the lesions retained in the main assessment dataset will be assigned to a separate exploratory/calibration image pool and will not be included in the formal main assessment dataset.
The allocation of lesions to the main assessment dataset or the exploratory/calibration pool will be completed before formal image scoring. When more than three lesions are available from a participant, lesions with clearer recent clinical history regarding activity, stability, or repigmentation will be preferentially retained in the main assessment dataset. If several lesions have similarly clear clinical information, allocation will aim to preserve representation of active/progressive, stable, and repigmented/regressive lesions when possible.
The exploratory/calibration image pool will be used for initial exploratory review, refinement of morphological terminology, preparation of evaluator training material, and calibration of scoring rules. These images will not be used as confirmatory evidence for the primary analysis.
Morphological assessment items will be developed from the literature and refined through the calibration process. This process will be used to standardize terminology and scoring rules among dermatologist evaluators before formal image evaluation.
After the scoring form is finalized, coded images from the main assessment dataset will be evaluated by dermatologist evaluators using a 0-3 visibility scoring system. To reduce observer bias, images will be presented without participant identity, lesion code, clinical lesion category, treatment information, or clinical history.
Complete blinding to imaging modality may not be possible because the imaging modalities have characteristic color and light features. This will be considered a methodological limitation. However, the coded and randomized image review process is intended to reduce recognition bias, recall bias, and assessment-order bias.
- Conditions
- Vitiligo
- Keywords
- Dermoscopy, Sub-ultraviolet reflectance imaging, Ultraviolet fluorescence dermoscopy, Vitiligo activity, Vitiligo stability, Vitiligo morphological findings, Repigmentation, Polarized dermoscopy
- Medical subject headings
- Vitiligo
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 |
|---|---|---|
| Adults With Vitiligo | Adult participants with clinically diagnosed vitiligo who will undergo close-up dermoscopic imaging of one to three clinically suitable vitiligo lesions during a single study visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of total visibility scores between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy
For each participant, the index lesion will be evaluated in polarized dermoscopy and sub-ultraviolet reflectance dermoscopy images. Selected lesion morphology items on the finalized scoring form will be scored from 0 to 3, where 0 indicates absent or not visible and 3 indicates clearly visible. A total visibility score will be calculated for each modality, and the paired within-lesion difference between the two modalities will be analyzed.
Measured: Day 1
Secondary outcomes (4)
Visibility scores of individual lesion morphology items across imaging modalities
Individual lesion morphology items on the finalized scoring form will be evaluated using a 0-3 visibility scoring system, where 0 indicates absent or not visible and 3 indicates clearly visible. Scores will be assessed across polarized dermoscopy, sub-ultraviolet reflectance dermoscopy, and ultraviolet fluorescence dermoscopy.
Measured: Day 1
Detection rates of individual lesion morphology items after dichotomization of visibility scores
Visibility scores will be dichotomized for each lesion morphology item, with a score of 0 defined as not detected and scores of 1, 2, or 3 defined as detected. Detection rates will be calculated and compared across imaging modalities.
Measured: Day 1
Assessment of ultraviolet and sub-ultraviolet optical findings
Optical findings observed in sub-ultraviolet reflectance dermoscopy and ultraviolet fluorescence dermoscopy will be assessed using the finalized scoring form. Depending on the finalized assessment item, findings may be recorded either as 0-3 visibility scores or as binary detection variables. These findings may include lesion-to-surrounding skin contrast, border visibility, perifollicular optical changes, and intralesional heterogeneity.
Measured: Day 1
Inter-rater agreement for lesion morphology assessment
Agreement between dermatologist evaluators will be assessed for visibility scores and/or binary detection of lesion morphology items using appropriate agreement statistics.
Measured: Through completion of image evaluation, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sueda Sanli Arikan, Istanbul Training and Research Hospital
- Investigators
- Ayşe Esra Koku Aksu, Professor, Study chair, University of Health Sciences Istanbul Training and Research Hospital, Dermatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846969
- Sponsor's protocol ID
- IstanbulTRH-DERM-VITSUV-2026
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Morphological Findings Related to Activity, Stability, and Repigmentation in Vitiligo Lesions Using Polarized Dermoscopy, Sub-Ultraviolet Reflectance Dermoscopy, and Ultraviolet Fluorescence Dermoscopy: A Cross-Sectional Observational Imaging Study
- ClinicalTrials.gov ID
- NCT07846969
- Acronym / sponsor ID
- IstanbulTRH-DERM-VITSUV-2026
- Conditions
- Vitiligo
- Keywords
- Dermoscopy, Sub-ultraviolet reflectance imaging, Ultraviolet fluorescence dermoscopy, Vitiligo activity, Vitiligo stability, Vitiligo morphological findings, Repigmentation, Polarized dermoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (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.
The goal of this observational study is to learn how different close-up skin imaging methods show vitiligo spots in adults with vitiligo. The study will look at skin changes that may be related to whether a vitiligo spot is active, stable, or gaining color again.
The main question it aims to answer is: Can special light-based imaging methods show useful details of vitiligo spots differently than regular polarized dermoscopy?
Participants will have vitiligo spots photographed during one study visit. Researchers will take images using polarized dermoscopy, sub-ultraviolet reflectance imaging, and ultraviolet fluorescence dermoscopy. Dermatologists will later review the coded images and score how clearly selected skin features can be seen.
The study will not change participants' treatment. It will not include blood tests, biopsy, injections, or any other invasive procedure.
Detailed description
This is a single-center, cross-sectional observational imaging study in patients with clinically diagnosed vitiligo.
During a single study visit, demographic and clinical information will be recorded, including disease duration, recent disease course, current treatment status, and patient-reported changes in selected lesions. One to three clinically suitable vitiligo lesions will be included in the main assessment dataset for each participant. Genital lesions will not be evaluated due to practical imaging limitations, hygiene considerations, and participant comfort.
Each selected lesion will be imaged using the Casio DZ-D100-AEA device, which allows simultaneous acquisition of digital contact polarized dermoscopy, digital contact non-polarized dermoscopy, and sub-ultraviolet reflectance dermoscopy images from the same lesion area with a single image capture. This approach is intended to improve within-lesion comparability between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy. Non-polarized images will be obtained as an automatic device output but will not be included in the routine analysis. Ultraviolet fluorescence dermoscopy images will be obtained from the same selected lesion using the DermLite DL5 handheld ultraviolet dermoscope with a smartphone adapter.
For each participant, one lesion will be designated as the index lesion for the primary analysis. If available, the second and third lesions in the main assessment dataset may be used for secondary and exploratory analyses. In participants with more than three imaged lesions, additional lesion images beyond the lesions retained in the main assessment dataset will be assigned to a separate exploratory/calibration image pool and will not be included in the formal main assessment dataset.
The allocation of lesions to the main assessment dataset or the exploratory/calibration pool will be completed before formal image scoring. When more than three lesions are available from a participant, lesions with clearer recent clinical history regarding activity, stability, or repigmentation will be preferentially retained in the main assessment dataset. If several lesions have similarly clear clinical information, allocation will aim to preserve representation of active/progressive, stable, and repigmented/regressive lesions when possible.
The exploratory/calibration image pool will be used for initial exploratory review, refinement of morphological terminology, preparation of evaluator training material, and calibration of scoring rules. These images will not be used as confirmatory evidence for the primary analysis.
Morphological assessment items will be developed from the literature and refined through the calibration process. This process will be used to standardize terminology and scoring rules among dermatologist evaluators before formal image evaluation.
After the scoring form is finalized, coded images from the main assessment dataset will be evaluated by dermatologist evaluators using a 0-3 visibility scoring system. To reduce observer bias, images will be presented without participant identity, lesion code, clinical lesion category, treatment information, or clinical history.
Complete blinding to imaging modality may not be possible because the imaging modalities have characteristic color and light features. This will be considered a methodological limitation. However, the coded and randomized image review process is intended to reduce recognition bias, recall bias, and assessment-order bias.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Vitiligo | – | –Adult participants with clinically diagnosed vitiligo who will undergo close-up dermoscopic imaging of one to three clinically suitable vitiligo lesions during a single study visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinically diagnosed vitiligo who attend the dermatology outpatient clinic and have at least one clinically suitable non-genital vitiligo lesion for dermoscopic imaging.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Clinical diagnosis of vitiligo
- Presence of at least one clinically suitable non-genital vitiligo lesion for dermoscopic imaging
- Ability and willingness to provide written informed consent
Key exclusion criteria (4 listed)
- Uncertain clinical diagnosis of vitiligo or presence of another hypopigmented or depigmented disorder that may interfere with lesion evaluation
- Absence of any clinically suitable non-genital vitiligo lesion for imaging
- Inability to cooperate with the imaging procedure
- Refusal or inability to provide written informed consent
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
Comparison of total visibility scores between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy
Time frame: Day 1
For each participant, the index lesion will be evaluated in polarized dermoscopy and sub-ultraviolet reflectance dermoscopy images. Selected lesion morphology items on the finalized scoring form will be scored from 0 to 3, where 0 indicates absent or not visible and 3 indicates clearly visible. A total visibility score will be calculated for each modality, and the paired within-lesion difference between the two modalities will be analyzed.
4 secondary outcomes
Visibility scores of individual lesion morphology items across imaging modalities
Time frame: Day 1
Detection rates of individual lesion morphology items after dichotomization of visibility scores
Time frame: Day 1
Assessment of ultraviolet and sub-ultraviolet optical findings
Time frame: Day 1
Inter-rater agreement for lesion morphology assessment
Time frame: Through completion of image evaluation, up to 6 months
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ayşe Esra Koku Aksu, Professor study chair
University of Health Sciences Istanbul Training and Research Hospital, Dermatology Department
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 Vitiligo, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 29 Sep 2026. 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 Turkey (Türkiye). 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 Sueda Şanlı Arıkan, Dermatology Resident Physician (+90 5362483355, sueda.sanli.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of total visibility scores between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy (time frame: Day 1). 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 29 Sep 2026.