A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Washington, D.c.
Centers for Vulvovaginal Disorders, DC
RECRUITING
Washington D.c.
Florida
Centers for Vulvovaginal Disorders, FL
RECRUITING
Tampa
New York
Centers for Vulvovaginal Disorders, NY
RECRUITING
New York
Contact Information
Primary
Andrew T Goldstein, MD
obstetrics@yahoo.com
4102790209
Backup
Sylvia Lorenzini
sylvia@vulvodynia.com
Time Frame
Start Date:2024-10-16
Estimated Completion Date:2025-10-16
Participants
Target number of participants:100
Treatments
Active_comparator: Investigational product
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.
Placebo_comparator: Placebo
This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based.