An interventional study of Treatment with Monalisa Glide Laser and Treatment with Clobetasol in Lichen Sclerosus, sponsored by Kantonsspital Winterthur KSW. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Kantonsspital Winterthur KSW · Not applicable, Interventional, and Treatment
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.
Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.
Exclusion Criteria:
3 monthly fractional laser treatment according to the user manual (correct applicator, vulvar and vaginal preset). In between daily local skin care with a drug free product of patients' choice.
Device: Treatment with Monalisa Glide Laser
Maintenance treatment with vulvar TCS (clobetasol) application 2x/week. Instruction given at trial start and monthly check up for treatment control Daily local skin care with a drug free product of patients' choice.
Drug: Treatment with Clobetasol
3 fractional laser treatment-sessions with Monalisa Glide
Application of Clobetasol twice per week
Lichen Score
The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT
Time frame: 3 months
Lichen Score Follow up
Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)
Time frame: 15 months
Vulva assessment Scale
Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)
Time frame: 15 months
German Pelvic floor questionnaire
Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT
Time frame: 15 months
Plan to share: No
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Lichen Sclerosus et Atrophicus→
Kantonsspital Winterthur KSW