Status:
RECRUITING
Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus
Lead Sponsor:
Kantonsspital Winterthur KSW
Conditions:
Lichen Sclerosus
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06135402
Start Date
November 10 2023
End Date
November 1 2027
Last Update
September 23 2025
Active Locations (1)
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1
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland, 8401