Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus

What this Trial Is About

Researchers are evaluating the effect of laser maintenance therapy compared to the standard maintenance treatment with clobetasol propionate in female patients with vulvar lichen sclerosus, a chronic inflammatory skin disorder that can cause scarring, sexual dysfunction, and risk of malignancy. This trial aims to compare the effectiveness and duration of benefits of fractional CO2-laser treatment against topical corticosteroid maintenance therapy. Participants receive either three monthly sessions of fractional laser treatment using the Monalisa Glide device along with daily drug-free skin care, or maintenance treatment with topical clobetasol applied twice weekly, also combined with daily drug-free skin care. The clobetasol group receives instruction at trial start and monthly checks to monitor treatment adherence. During the study, participants will undergo assessments including the Lichen Score at 3 months as the primary outcome, and follow-up measures at 15 months such as the Lichen Score, Vulva Assessment Scale, and German Pelvic Floor Questionnaire. The trial is randomized and single-blinded, with ongoing monitoring of treatment effects over the study period. Participation involves regular visits for treatment and evaluations to track skin condition and quality of life.

Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus