NCT06662942 StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
| NCT ID | NCT06662942 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Andrew T. Goldstein, MD |
| Condition | Vulvar Lichen Sclerosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2025-10-16 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
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