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New treatment option for Vulvar Lichen Sclerosus
Official title StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
ClinicalTrials.gov ID: NCT06662942
What this study is testing
What is StrataMGT?
StrataMGT is an investigational medicine, given as a treatment applied to 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
- This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Female, 18 years or older.
- With a diagnosis of biopsy proven vulvar lichen sclerosus.
- Signed written informed consent.
- Willingness and ability to comply with the study requirements.
- Subject must have a score of 10 or greater in the VQLI at screening.
You likely can't join if
- Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
- Who suffer from a topical or systemic infections (bacterial, viral or fungal) at the time of screening. people who screen positive for either...
- Who have been diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma of the vulva.
- Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of...
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
See the full eligibility criteria
- Female, 18 years or older.
- With a diagnosis of biopsy proven vulvar lichen sclerosus.
- Signed written informed consent.
- Willingness and ability to comply with the study requirements.
- Subject must have a score of 10 or greater in the VQLI at screening.
- Must be on a stable regimen of topical corticosteroids or topical calcineurin inhibitor for at least 2 months prior to the screening visit.
- Women currently on a stable regimen of intravaginal estrogen therapy for at least 2 months may remain on the estrogen therapy throughout the study.
- Women currently using topical estrogen therapy on the vulva must stop two weeks prior to enrolling in the study.
- Women must have a culture negative for candidiasis or bacterial vaginosis at screening.
- Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
- Who suffer from a topical or systemic infections (bacterial, viral or fungal) at the time of screening. people who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and...
- Who have been diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma of the vulva.
- Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
- Who are uncooperative, known to miss appointments (according to people' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- New York, New York, United States
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 Washington D.C., District of Columbia, United States; Tampa, Florida, United States; New York, New York, United States. 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.