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

Kantonsspital Winterthur KSW

Status: Enrolling

Conditions: Lichen Sclerosus

Treatments: Device: Treatment with Monalisa Glide Laser; Drug: Treatment with Clobetasol

Study type: Interventional

Funder types: Other

Identifiers

NCT06135402

Laser-Lichen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Laser group

Experimental group

Description:

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.

Treatment:

Device: Treatment with Monalisa Glide Laser

Clobetasol group

Active Comparator group

Description:

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.

Treatment:

Drug: Treatment with Clobetasol