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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of total visibility scores between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Comparison of total visibility scores between polarized dermoscopy and sub-ultraviolet reflectance dermoscopy
时间窗: 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.
次要结局
- Visibility scores of individual lesion morphology items across imaging modalities(Day 1)
- Detection rates of individual lesion morphology items after dichotomization of visibility scores(Day 1)
- Assessment of ultraviolet and sub-ultraviolet optical findings(Day 1)
- Inter-rater agreement for lesion morphology assessment(Through completion of image evaluation, up to 6 months)
研究者
Sueda Sanli Arikan
Dermatology Resident Physician
Istanbul Training and Research Hospital