NCT04148651

The CO2RE® System for Vulvar Lichen Sclerosus

Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Candela Corporation · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	The CO2RE® System	The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).

Timeline

• Start date: 2018-07-11
• Primary completion: 2020-07-30
• Completion: 2020-12-17
• First posted: 2019-11-01
• Last updated: 2022-03-22
• Results posted: 2021-01-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study