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 will be randomized to receive either placebo gel or treatments with the investigation product, StrataMGT TM 1:1 ratio. The primary efficacy endpoint will be change in score on the Vulvar Quality of Life Index 11 (VQLI). Secondary efficacy endpoints will be the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO). All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
Centers for Vulvovaginal Disorders, DC
Washington D.C., District of Columbia, United States
RECRUITINGCenters for Vulvovaginal Disorders, FL
Tampa, Florida, United States
RECRUITINGCenters for Vulvovaginal Disorders, NY
New York, New York, United States
RECRUITINGVulvar Quality of Life Index 11 (VQLI)
The VQLI is used to "assess symptomatic, psychosexual and physical aspects of vulvar disease" \[1\] using the following scale: Very Much, A Lot, A Little, and Not At All. The questionnaire consists of 15 questions.
Time frame: throughout the study, averaging 3.5 months
Skindex 29
The Skindex 29 is a subjective survey used to assess which skin conditions have bothered a patient the most on the following scale: All the time, often, sometimes, rarely, and never. The survey consists of 30 questions.
Time frame: throughout the study, averaging 3.5 months
Clinical Scoring System for Vulvar Lichen Sclerosus
The Clinical Scoring System for Vulvar Lichen Sclerosus is a subjective and objective survey filled out by the patient and provider. It is used to assess the patient's severity of subjective symptoms and the provider's interpretation of the severity of visible symptoms associated with vulvar LS.
Time frame: throughout the study, averaging 3.5 months
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