💬In plain words
What the trial is, and whether it could suit you
Vulvar lichen sclerosus is a chronic inflammatory skin disease affecting the vulva and genital region, which may cause intense pruritus, pain, burning sensations, and progressive scarring. In severe cases, the disease may lead to significant anatomical changes, sexual dysfunction, and a reduction in quality of life.
First-line treatment for vulvar lichen sclerosus consists of high-potency topical corticosteroids. Although many patients experience symptom relief, a considerable number of women continue to have persistent symptoms or progressive anatomical damage. For these patients, therapeutic options are limited.
MTX is an immunomodulatory medication that has been used for several decades in the treatment of inflammatory and autoimmune diseases. Previous clinical observations suggest that MTX may be beneficial for patients with severe or treatment-resistant vulvar lichen sclerosus; ho
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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