Evaluating Methotrexate for Severe Vulvar Lichen Sclerosus in a Phase II Open-Label Pilot Study

What this Trial Is About

Vulvar lichen sclerosus is a chronic inflammatory skin condition affecting the vulva and genital area, causing symptoms like itching, pain, burning, and scarring that can lead to anatomical changes and sexual dysfunction. This research aims to evaluate the use of subcutaneous injectable methotrexate (MTX), an immunomodulatory drug, in women with severe vulvar lichen sclerosus who have not responded well to standard high-potency topical corticosteroids. The study is a phase II pilot trial designed to explore the safety and potential benefits of weekly MTX treatment over 12 months. Participants will receive weekly injections of methotrexate starting at 12.5 mg, with possible dose adjustments based on their response and safety monitoring. Folic acid supplements will be given the day after each MTX injection to help reduce side effects. The trial follows a single group design, with clinical and laboratory assessments every three months during the year-long treatment period. Photographic documentation will also be used to track changes in vulvar skin morphology. During the study, women will report their symptoms such as itching, pain, and burning, while clinicians will evaluate physical changes using standardized scoring tools and photos reviewed by independent experts. Safety will be closely monitored through laboratory tests and recording any side effects or treatment discontinuations. The main goal is to see if MTX improves symptoms and stabilizes skin changes, while also looking at quality of life and treatment tolerability over the 12 months of participation.

Methotrexate for Severe Vulvar Lichen Sclerosus