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

• Status: Recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kantonsspital Winterthur KSW
• Treatments: Clobetasol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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