The CO2RE® System for Vulvar Lichen Sclerosus

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

July 11, 2018

Primary Completion Date

July 30, 2020

Study Completion Date

December 17, 2020

Conditions
Vulvar Lichen Sclerosus
Interventions
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).

Trial Locations (4)

32204

Total Dermatology Care Center, Jacksonville

32207

Center for Modern Aesthetic Medicine, Jacksonville

45249

HERmd (formerly Somi Javaid M.D. & Associates), Cincinnati

05403

Lumina Med Spa, South Burlington

Sponsors
All Listed Sponsors
lead

Candela Corporation

INDUSTRY

NCT04148651 - The CO2RE® System for Vulvar Lichen Sclerosus | Biotech Hunter | Biotech Hunter