MERCURE study: MEthotrexate in ReCurrent dVIN

Condition studied

dVIN caused by Lichen Sclerosus

Investigational medicinal product(s)

Eligibility

Primary endpoint

To assess effectiveness of MTX in prevention of recurrence in dVIN, recurrence rates with or without MTX will be compared within this prospective self-controlled pilot study, as each patient functions as its own control., Time-to recurrence of dVIN in women with lichen sclerosus and recurrent dVIN lesions with- and without the use of MTX will also be assessed by determination of clinical responses at 1-3-6-9-12-15-18 months and will be identified as stable disease (SD) or progressive disease (PD).

Endpoint detail

Safety and tolerability of side effects, reduction of vulvar complaints, reduction of topical corticosteroid application and patient satisfaction with the use of MTX will be evaluated by patient reported use and documentation of side effects using a questionnaire. Severity of side effects will be evaluated according to the CTCEA version 5.0 2017., Pre-treatment and, when performed, current- or post-treatment biopsies will be identified and central blinded pathology revision will be performed. To explore microenvironment in recurrent dVIN with and without the use of MTX immunohistochemistry staining, including p53 will be performed.