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Recruiting NCT06135402

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

Trial Parameters

Condition Lichen Sclerosus
Sponsor Kantonsspital Winterthur KSW
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-11-10
Completion 2027-11-01
Interventions
Treatment with Monalisa Glide LaserTreatment with Clobetasol

Brief Summary

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.

Eligibility Criteria

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 probl

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