Could a common arthritis drug ease a devastating skin condition?
NCT ID NCT07352917
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether methotrexate, a drug used for arthritis, can help women with severe vulvar lichen sclerosus that hasn't improved with standard steroid creams. Twelve women will receive weekly injections of methotrexate for 12 months. The goal is to see if symptoms and skin changes get better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- methotrexate
- What this could lead to
- If it works, this could point toward a new treatment option for women with severe vulvar lichen sclerosus who do not respond to standard creams.
- What could go wrong
- This is a very small pilot study with only 12 participants, so results may not apply broadly. Methotrexate can cause side effects like nausea, liver issues, and increased infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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DermoCentro
RECRUITINGSão José dos Campos, São Paulo, 12245760, Brazil
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