The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial.

BACKGROUND: Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to direct therapy for VLP. This randomised controlled trial will be the first double-blinded study comparing systemic treatments in VLP and aims to investigate the safety and efficacy of deucravacitinib compared to methotrexate, in patients with VLP who have failed treatment with potent topical corticosteroids. METHODS: A total of 116 women aged ≥ 18 years with moderate to severe VLP (Genital Erosive Lichen Planus (GELP) score ≥ 5) will be recruited. All participants will initially be treated with Diprosone® OV daily, and their outcome will be assessed using the GELP score. At 8 weeks' follow-up, responders (GELP < 5) will be continued on Diprosone® OV. Non-responders (GELP ≥ 5) will be randomised 1:1 in a blinded fashion to receive (i) methotrexate 10 mg weekly + placebo tablet twice daily + folic acid 5 mg weekly or (ii) deucravacitinib 6 mg twice daily + placebo tablet weekly + folic acid 5 mg weekly. The primary endpoint is the difference in the mean change of GELP scores from baseline to week 32 between deucravacitinib and methotrexate groups. DISCUSSION: High-quality evidence guiding the management of women with VLP is lacking. Once completed, this will be the first double-blinded RCT to compare systemic treatments in VLP. The results of this study will provide valuable, high-quality data to guide second-line therapy options for VLP that is recalcitrant to potent topical corticosteroids. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12623000682640. Registered on 26 June 2023.

Vulvar Melanoma.

This case report describes an ulcerated, erythematous, and hyperpigmented periurethral nodule with surrounding irregular macular hyperpigmentation.

Vulvar quality of life index (VQLI) - A simple tool to measure quality of life in patients with vulvar disease.

BACKGROUND/OBJECTIVES: Vulvar disease leads to significant disease burden and reduced quality of life (QOL). However, vulvar disease-specific instruments to measure QOL are lacking. We developed the Vulvar Quality of Life Index (VQLI) to comprehensively and reproducibly assess symptomatic, psychosexual and physical aspects of vulvar disease. METHODS: The VQLI was inferred from a review of the literature regarding QOL of vulvar disease, and responses from a cohort of patients attending specialist clinics. Seven domains and a 15-item questionnaire were developed. This was tested and optimised prior to validation on 248 women, using a control group as a baseline. The VQLI was further tested on 157 women, and the total VQLI score was compared to a self-determined Likert global score on how vulvar disease had impacted their overall health. RESULTS: The VQLI had excellent internal consistency (Cronbach's alpha, 0.93), and test-retest reliability showed that 9/15 questions had a substantial weighted kappa value of 0.5 or above, with good intraclass correlation coefficient (0.88; CI 0.8-0.93). Spearman correlations were consistently positive. Further testing on 157 women demonstrated a significant relationship between the total VQLI score and the effect of vulvar disease on overall health, with high levels of the impact of vulvar disease on overall health associated with high total VQLI score (P < 0.001). CONCLUSIONS: The VQLI is a validated, fast and reliable tool to measure the global impact of vulvar disease on QOL and can be used to monitor response to treatment or in a research setting.