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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-10-16 with a primary completion date of 2025-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Chailee Moss, MD
STUDY DIRECTOR
Centers for Vulvovaginal Disorders, DC
Frequently Asked Questions
Who can join the NCT06662942 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvar Lichen Sclerosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06662942 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06662942 currently recruiting?
Yes, NCT06662942 is actively recruiting participants. Contact the research team at obstetrics@yahoo.com for enrollment information.
Where is the NCT06662942 trial being conducted?
This trial is being conducted at Washington D.C., United States, Tampa, United States, New York, United States.
Who is sponsoring the NCT06662942 clinical trial?
NCT06662942 is sponsored by Andrew T. Goldstein, MD. The principal investigator is Chailee Moss, MD at Centers for Vulvovaginal Disorders, DC. The trial plans to enroll 100 participants.