Methotrexate treatment for severe vulvar lichen sclerosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open‑label Phase 2 interventional study testing methotrexate in patients with severe vulvar lichen sclerosus. Eligible participants must have histopathological confirmation, a Vulvar Quality of Life Index (VQLI) score above 24, and persistent disease after at least three months of high‑potency topical corticosteroids. Baseline labs (CBC, liver and kidney function, and viral serologies) must be normal and women of childbearing potential require a negative pregnancy test. Clinical response will be tracked over time using a standardized clinical scoring system for vulvar lichen sclerosus.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of genital lichen sclerosus et atrophicus (vulvar, perineal, or perianal);
* Histopathological diagnosis of genital lichen sclerosus et atrophicus;
* Disease severity defined according with a score above 24 on the Vulvar Quality of Life Index (VQLI);
* Failure of symptom regression or progressive genital deformity after at least 3 months of treatment with a high-potency topical corticosteroid;
* Normal baseline laboratory evaluation, including complete blood count, liver and kidney function tests, and negative serologies for HIV and hepatitis B and C;
* For women of childbearing potential, a negative pregnancy test at screening.

Exclusion Criteria (assessed before signing the Informed Consent Form):

* Lack of full mental or psychiatric capacity;
* Need for assistance from a third party (legal guardian) to participate in the study;
* Significant difficulty in understanding or expressing oneself in Portuguese;
* Unavailability or inability to complete Likert-scale questionnaires;
* Inability to comply with study requirements, including adherence to the treatment schedule and attendance at follow-up visits;
* Unrealistic expectations regarding treatment benefits or the possibility of adverse effects;
* Intention to become pregnant during the study period;
* Refusal to adopt at least one adequate contraceptive method (hormonal or barrier) in women of childbearing potential;
* Poor adherence to the commitment to abstain from alcoholic beverages;
* Uncontrolled autoimmune comorbidities;
* Refusal to sign the Informed Consent Form after adequate explanation and clarification of doubts;
* Any indication of inability to comply with the conditions established in the research protocol. Decisions will be made to ensure participant safety and study integrity, with appropriate communication regarding the reasons for exclusion.

Exclusion Criteria (assessed after signing the Informed Consent Form):

* Elevation of liver enzymes above normal limits or impaired renal function during laboratory monitoring. Exclusion refers to discontinuation of the experimental intervention; however, the participant will continue to receive comprehensive medical follow-up as needed;
* Pregnancy. The participant will be withdrawn from the study intervention and referred for obstetric care, while continuing to receive medical follow-up;
* Lack of cooperation, failure to attend scheduled follow-up visits, or failure to undergo required laboratory monitoring;
* Any other condition that limits the participant's ability to comply with study procedures, as determined by the responsible investigator.

Where it's running

• DermoCentro
  São José dos Campos, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Samir Arbache, Phd
• Email: samir.arbache@gmail.com
• Phone: +55 12 981221011

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.