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

Laser-Lichen

With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

2023-11-10

2026-11-01

2026-11-01

Recruiting

120

Inclusion Criteria: * Pre- or postmenopausal * 12 weeks of continuous topical clobetasol treatment completed. * Written informed consent * German speaking (Study information and IC available only in German) Exclusion Criteria: * Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use * Contraindication for the use of topic clobetasol * History of vulva laser * Immune-suppression * Pregnancy or planned pregnancy, breast feeding. * Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer. * History of vulvar or pelvic radiation therapy * Uncertain vulvar findings, which require a biopsy. * Acute vulvitis, especially recurrent genital herpes * History of vaginal mesh implantation within 6 months preceding this study * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject * Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation * Previous enrolment into the current investigation * Enrolment of the PI, his/her family members, employees and other dependent persons

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric, prospective, randomized, single-blinded, active-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-11-18