Clinical trial NCT06135402: Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lichen Sclerosus
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, prospective, randomized, single-blinded, active-controlled
Primary purpose: TREATMENT

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) 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.

Eligibility 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

Primary outcomes:
measure: Lichen Score
timeFrame: 3 months
Secondary outcomes:
measure: Lichen Score Follow up
timeFrame: 15 months
measure: Vulva assessment Scale
timeFrame: 15 months
measure: German Pelvic floor questionnaire
timeFrame: 15 months
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zürich
Study officials:
affiliation: Clinic of obstetrics and gynecology
name: Gesine Meili, MD
role: PRINCIPAL_INVESTIGATOR
References: