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

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Abstract

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.

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The data supporting this review's findings are available from the corresponding author upon reasonable request.

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  1. Marissa S. Ceresnie and Elizabeth Warbasse have contributed equally to this work.

Authors and Affiliations

  1. Department of Dermatology, Henry Ford Health, 3031 W. Grand Blvd, Suite 700, Detroit, MI, 48202, USA

    Marissa S. Ceresnie, Aunna Pourang & Iltefat H. Hamzavi

  2. Department of Dermatology and Cutaneous Surgery, University of South Florida Morsani College of Medicine, Tampa, FL, USA

    Elizabeth Warbasse

  3. Wayne State University School of Medicine, Detroit, MI, USA

    Sarah Gonzalez

  4. Department of Dermatology, Wayne State University School of Medicine, Detroit, MI, USA

    Aunna Pourang

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Contributions

Conceptualization: EW, AP, IHH; methodology: EW, AP; literature search and data analysis: MSC, EW, SG; writing—original draft preparation: MSC, EW; writing—review and editing: MSC, IHH; supervision: IHH.

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Correspondence to Iltefat H. Hamzavi.

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Conflict of interest

MSC is a sub-investigator for Avita Medical, Incyte Corporation, Clinuvel Pharmaceuticals, and the Immune Tolerance Network. IHH helped develop the vitiligo area scoring index and has served as an advisory board member for AbbVie; a consultant for Incyte Corporation, Pfizer, and UCB; a principal investigator for AbbVie, Allergan, Avita Medical, Bayer, Clinuvel Pharmaceuticals, Estée Lauder, Ferndale Laboratories, Galderma Laboratories LP, GE Healthcare, Incyte Corporation, Janssen, Janssen Biotech, Johnson & Johnson, Lenicura, LEO Pharma, Pfizer, The Immune Tolerance Network, and Unigen; a sub-investigator for Amgen, Bristol Myers Squibb, Foamix Pharmaceuticals, and Janssen; past-president of the Hidradenitis Suppurativa Foundation; and co-chair of the Global Vitiligo Foundation.

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This is a scoping review and does not include information or images which could identify or potentially identify individuals.

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Ceresnie, M.S., Warbasse, E., Gonzalez, S. et al. Implementation of the vitiligo area scoring index in clinical studies of patients with vitiligo: a scoping review. Arch Dermatol Res 315, 2233–2259 (2023). https://doi.org/10.1007/s00403-023-02608-3

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