Methotrexate for Differentiated vulvar intraepithelial neoplasia (dVIN)|Lichen sclerosus

Inclusion criteria

• {"criterion_text":"- Age of 18 years or older."}
• {"criterion_text":"- Failure to standard therapy with intensive clobetasol ointment either or not combined with tacrolimus 0,1% ointment. Failure to standard therapy is defined by complaints of lichen sclerosus which are insufficiently controlled by the topical therapy."}
• {"criterion_text":"- Recurrent dVIN lesions, at least 1 previous dVIN, for which surgical treatment has been performed."}

Exclusion criteria

• {"criterion_text":"- Concomitant diagnoses of vulvar cancer"}
• {"criterion_text":"- Insufficient knowledge of the Dutch or English language"}
• {"criterion_text":"- Alcohol abuse."}
• {"criterion_text":"- Oral or gastro-intestinal ulcera or stomatitis"}
• {"criterion_text":"- Recently received a live attenuated vaccine or when in need of receiving a live attenuated vaccine."}
• {"criterion_text":"- Severe decreased liver function with a serum bilirubin value >85,5umol/l or >5mg/dl"}
• {"criterion_text":"- Severe decreased kidney function with creatinine clearance of <30ml/min"}
• {"criterion_text":"- Bone marrow diseases (including leukopenia, thrombocytopenia, anemia, bone marrow hypoplasia)"}
• {"criterion_text":"- Acute or chronic infections (including HIV/AIDS, tuberculosis)"}
• {"criterion_text":"- Immunodeficiency or immunosuppressive medication"}
• {"criterion_text":"- Severe pulmonary disease"}
• {"criterion_text":"- Pregnancy or current pregnancy wish"}
• {"criterion_text":"- Legal incapability"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Recurrence rates compared within a prospective self-controlled pilot study; each patient functions as their own control."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Clinical responses assessed at 1, 3, 6, 9, 12, 15 and 18 months and classified as stable disease (SD) or progressive disease (PD); used to determine time-to-recurrence."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported questionnaires documenting use and side effects; severity graded according to CTCAE v5.0 (2017)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Central blinded pathology revision of biopsies; immunohistochemistry (including p53) to explore tumor microenvironment."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-04-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

13

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Catharina Onderzoeksfonds","duties_or_roles":"Source of monetary support","organisation_type":""}