Implementation of the vitiligo area scoring index in clinical studies of patients with vitiligo: a scoping review.

The vitiligo area scoring index (VASI) is a validated, reliable clinician-reported outcome measure widely used to assess the extent of skin depigmentation seen in patients with vitiligo and to measure patient responses to therapies for vitiligo in clinical trials. However, its implementation in studies is inconsistent and makes comparing results across different studies difficult. The aim of this scoping review is to summarize interventional clinical studies that applied the VASI to measure vitiligo and identify variability in VASI implementation. A systematic search of Ovid Medline, Embase, Web of Science, Cochrane, and ClinicalTrials.gov was performed. Interventional studies published between January 1946 and October 2020 that used the VASI as an outcome measure for assessing vitiligo response were reviewed for methodological approach. Great heterogeneity was found within the 55 included interventional studies that used VASI as an outcome measure. A total of 9 VASI subtypes were described by the authors within 10 intervention categories. VASI determined study eligibility in one study. Body surface area was most frequently established using inconsistent methods. We found unclear or ambiguously scaled assessments of depigmentation. Most VASI outcomes were reported as mean absolute difference, percentage VASI improvement, and percentage of patients who achieved the VASI endpoint. The VASI score was over 100 in one study. Our scoping review revealed many VASI methodology variations in interventional clinical studies of vitiligo. While VASI is a standard method to measure vitiligo changes, substantial heterogeneity in methodology limits reliable comparison and interpretation of findings from different clinical trials. Our findings may be used as a foundation to standardize the VASI outcome measure methodology, allowing for improved clinician training and rigorous data analysis across vitiligo research groups worldwide.