The CO2RE® System for Vulvar Lichen Sclerosus

Inclusion criteria

• . Able to read, understand and sign informed consent for study participation;
• . Female subjects with age 18-80 years;
• . Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
• . Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
• . Topical corticosteroid treatment, if any, will be continued during the study period;
• . Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
• . One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
• . No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.

Exclusion criteria