Andrew T. Goldstein, MD
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
This will be a randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of StrataMGT for the management of the symptoms of vulvar lichen sclerosus. Up to 100 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from two centers. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar intrepithelial neoplasia (VIN) or carcinoma. All eligible patients wil…
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 to…
StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
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