Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment with Monalisa Glide Laser, Treatment with Clobetasol.
- Who it may be relevant to
- Registry conditions: Lichen Sclerosus. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Treatment with Monalisa Glide Laser
3 fractional laser treatment-sessions with Monalisa Glide - Drug Treatment with Clobetasol
Application of Clobetasol twice per week
Primary outcome measures
- Lichen Score [Time frame: 3 months]
Secondary outcome measures (3)
- Lichen Score Follow up [Time frame: 15 months]
- Vulva assessment Scale [Time frame: 15 months]
- German Pelvic floor questionnaire [Time frame: 15 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Kantonsspital Winterthur — Winterthur
Identifiers
NCT: NCT06135402 · Laser-Lichen