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

Recruiting now · Not applicable

Conditions studied: Lichen Sclerosus

In brief

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.

Key facts

Study ID

NCT06135402

Run by

Kantonsspital Winterthur KSW

People needed

120

Starts

2023-11-10

Expected to finish

2027-11-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre- or postmenopausal
• 12 weeks of continuous topical clobetasol treatment completed.
• Written informed consent
• German speaking (Study information and IC available only in German)

You may not qualify if…

• 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

Where it is running

• Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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