StrataMGT for the Treatment of Vulvar Lichen Sclerosus

Not Applicable

Completed

• Conditions: Vulvar Lichen Sclerosus
• Interventions: Device: StrataMGT

• Registration Number: NCT06360705
• Lead Sponsor: Center for Vulvovaginal Disorders

Brief 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).

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-11
• Study Start: 2024-04-16
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exploratory Open Label	StrataMGT	Experimental: StrataMGT

Primary Outcome Measures

Name	Time	Method
Histopathologic Inflammation	10 weeks	Histopathologic inflammation that occurs with lichen sclerosus will be assessed by a dermatopathologist on 4mm punch biopsies performed during the screening visit (Week 0) and at the Week 10 visit using the following clinical scoring scale. The scale is from 0-3, 0 being no disease of inflammation and 3 being severe disease or inflammation.

Trial Locations

Locations (1)

Centers for Vulvovaginal Disorders; 🇺🇸 New York, New York, United States