StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms

Launched by ANDREW T. GOLDSTEIN, MD · Oct 25, 2024

Keywords

ClinConnect Summary

The clinical trial titled "StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms" is looking to test a new treatment called StrataMGT to see how well it can help manage the symptoms of vulvar lichen sclerosus, a condition that affects the skin in the genital area. This study is currently recruiting female participants aged 18 and older who have been diagnosed with vulvar lichen sclerosus through a biopsy. To be eligible, participants should have been using specific treatments like topical corticosteroids for at least two months and must be willing to follow the study guidelines.

If you choose to participate, you can expect to receive the StrataMGT treatment while continuing to follow your current medication plan, as long as you meet the criteria. The trial will monitor your symptoms and overall health during the study. It's important to note that certain health conditions or infections may disqualify you from participating, so the research team will conduct thorough screenings to ensure safety. This trial aims to provide valuable information about the safety and effectiveness of StrataMGT for women dealing with this condition.

Gender

FEMALE

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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. Subjects who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and retested and may participate if the confirmatory test after treatment is negative. Any vulvovaginal infections during their participation in the study will be considered an adverse event. The subject will then stop the study IP and will be treated for the infection and may resume use of the IP 3 days after the last dose of medication for the infection. They will be discontinued from the study if they have two infections during the study.
• • 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 subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.