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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Pre- or postmenopausal
• 12 weeks of continuous topical clobetasol treatment completed.
• Written informed consent
• German speaking (Study information and IC available only in German)
Locations
Other Locations
Switzerland
Kantonsspital Winterthur
RECRUITING
Winterthur
Contact Information
Primary
Rebecca R Zachariah, MD
rebecca.zachariah@ksw.ch
+41522663173
Backup
Susanne Forst
susanne.forst@ksw.ch
+41522663387
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 120
Treatments
Experimental: Laser group
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.
Active_comparator: Clobetasol group
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.
Related Therapeutic Areas
Sponsors
Leads: Kantonsspital Winterthur KSW