RecruitingPhase 1NCT06662942

StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms

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

Sponsor

Andrew T. Goldstein, MD

Enrollment

100 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

vulvar lichen sclerosus

Summary

This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called StrataMGT for people with vulvar lichen sclerosus. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStrataMGT

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.

DRUGPlacebo

The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.

Locations(3)

Centers for Vulvovaginal Disorders, DC

Washington D.C., District of Columbia, United States

Centers for Vulvovaginal Disorders, FL

Tampa, Florida, United States

Centers for Vulvovaginal Disorders, NY

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06662942

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