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

Conditions

• Vulvar Lichen Sclerosus

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Oct 16, 2024

Status verified

Nov 2024

Primary completion

Oct 16, 2025

Completion

Oct 16, 2025

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Vulvar Quality of Life Index 11 (VQLI) [ Time Frame: throughout the study, averaging 3.5 months ]

Central Contacts

• Andrew T Goldstein, MD
  4102790209
  [email protected]
• Sylvia Lorenzini
  [email protected]

Locations (3)

Find similar trials in Washington D.C., DC