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Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin disease of the anogenitalarea leading to itch, burning, sexual dysfunction and impaired quality of life. An unmet need in the context of LS is a practical, easily assessable grading scale to classify disease severity and to allow intra- and interindividual comparisons. The objectives of this study were i) to assess the prevalence and severity of 23 items proposed by a recent Delphi consensus group in patients with adult VLS. ii) to develop a clinical severity scale and, iii) to test the interrater reliability of this novel severity scale. A retrospective assessment of the prevalence and severity of 23 items in 143 patients was performed by using patient records and photo documentation to develop a novel clinical severity scale (i.e. the "Clinical Lichen Sclerosus Score" = CLISSCO) for VLS. Thereafter, the CLISSCO was validated by 16 raters. We found that the items proposed by the consensus group vary markedly in frequency and severity. Following selection of the most relevant items, the CLISSCO was developed consisting of 3 "Symptoms", 3 "Signs" and 6 "Architectural changes" rated on a 0-4 point Likert-scale. The intraclass correlation coefficient was excellent for each item, the applicability of the CLISSCO considered user-friendly by the raters. We conclude that the CLISSCO proved to be a user-friendly, reliable tool to assess disease severity in VLS. However, further studies are needed to validate its applicability and value in daily practice and clinical research.
