About this trial
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
This trial does not accept healthy volunteersQualifiers
Pre- or postmenopausal
12 weeks of continuous topical clobetasol treatment completed.
Written informed consent
German speaking (Study information and IC available only in German)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Treatment with Monalisa Glide Laser
Device3 fractional laser treatment-sessions with Monalisa Glide
Treatment with Clobetasol
DrugApplication of Clobetasol twice per week
Treatment groups
Trial outcomes
Primary outcomes
Lichen Score
The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT
Secondary outcomes
Lichen Score Follow up
Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)
Vulva assessment Scale
Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)
German Pelvic floor questionnaire
Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT
Sponsors and contacts
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