NCT06360705

StrataMGT for the Treatment of Vulvar Lichen Sclerosus

An Exploratory Open Label Trial of StrataMGT for the Treatment of Vulvar Lichen Sclerosus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Center for Vulvovaginal Disorders · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This will be an exploratory open label study to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus. 5 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from one center. This study will consist of a two-week screening period and an 8-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 8-week treatment period to rule out vulvar intraepithelial neoplasia (VIN) or carcinoma. All patients will have a 4mm punch biopsy at screening (week 0) and after 8 weeks of treatment (week 10). The primary efficacy variable will be performed by a dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and after treatment at the Week 10 visit (0 to 3 scale). Secondary efficacy endpoints will be change in score on the Vulvar Quality of Life Index (VQLI), the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	StrataMGT	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.

Timeline

• Start date: 2024-04-16
• Primary completion: 2024-10-30
• Completion: 2024-11-30
• First posted: 2024-04-11
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study