The CO2RE® System for Vulvar Lichen Sclerosus

Status Completed

Clinical Trial Summary

Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.

Clinical Trial Description

This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser. Investigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment. Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04148651
Study type	Interventional
Source	Candela Corporation
Contact
Status	Completed
Phase	N/A
Start date	July 11, 2018
Completion date	December 17, 2020

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