Using StrataMGT to reduce symptoms of vulvar lichen sclerosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: obstetrics@yahoo.com
• Phone: 4102790209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.