Using StrataMGT to reduce symptoms of vulvar lichen sclerosus

A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.

This study is testing if a new treatment called StrataMGT can help women with vulvar lichen sclerosus feel better and improve their quality of life.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Center for Vulvovaginal Disorders (Academic / other)
• Locations: 3 sites (Washington D.C., District of Columbia and 2 other locations)
• Trial ID: NCT06662942 on ClinicalTrials.gov

What this trial studies

This trial evaluates the efficacy and safety of StrataMGT in managing symptoms of vulvar lichen sclerosus through a randomized double-blind placebo-controlled design. Up to 100 female patients with biopsy-proven vulvar lichen sclerosus will be recruited from two centers. Participants will undergo a two-week screening period followed by a 12-week treatment phase, during which they will receive either the investigational product or a placebo. The primary outcome will be measured using the Vulvar Quality of Life Index 11, alongside secondary measures including the Skindex 29 and Clinical Lichen Sclerosus Scoring Scale.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older with a diagnosis of biopsy-proven vulvar lichen sclerosus and a VQLI score of 10 or greater.

Not a fit: Patients who are immunocompromised or have uncontrolled malignant diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from vulvar lichen sclerosus.

How similar studies have performed: While this approach is novel, similar studies have shown promise in managing lichen sclerosus symptoms with other interventions.

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.

Where this trial is running

Washington D.C., District of Columbia and 2 other locations

• Centers for Vulvovaginal Disorders, DC — Washington D.C., District of Columbia, United States (Recruiting)
• Centers for Vulvovaginal Disorders, FL — Tampa, Florida, United States (Recruiting)
• Centers for Vulvovaginal Disorders, NY — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Andrew T Goldstein, MD

Conditions Vulvar Lichen Sclerosus; StrataMGT