Assessment of Vitiligo Lesions Using Polarized Dermoscopy, Sub-Ultraviolet Reflectance Dermoscopy, and Ultraviolet Dermoscopy

ConditionVitiligo
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Adults With Vitiligo

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Day 1
3

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.

Time frame
Day 1
4

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.

Time frame
Through completion of image evaluation, up to 6 months

Other outcomes

Sponsors and contacts

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