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New treatment option for Vulvar Lichen Sclerosus
Official title Methotrexate for Severe Vulvar Lichen Sclerosus
ClinicalTrials.gov ID: NCT07352917
What this study is testing
What is Methotrexate (MTX)?
Methotrexate (MTX) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for vulvar lichen sclerosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- (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;
See the full eligibility 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.
- (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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São José dos Campos, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São José dos Campos, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.