StrataMGT for the Treatment of Vulvar Lichen Sclerosus

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06360705
Study type	Interventional
Source	Center for Vulvovaginal Disorders
Contact	Andrew Goldstein, MD
Phone	4102790209
Email	obstetrics@yahoo.com
Status	Recruiting
Phase	N/A
Start date	April 2024
Completion date	October 2024

View Details

See also
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