An interventional study of Treatment with Monalisa Glide Laser and Treatment with Clobetasol in Lichen Sclerosus, sponsored by Kantonsspital Winterthur KSW. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Kantonsspital Winterthur KSW · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 8 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 20 interventional studies indexed under Lichen Sclerosus et Atrophicus.
Browse Lichen Sclerosus et Atrophicus studies →Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Treatment with Monalisa Glide Laser
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.
Drug: Treatment with Clobetasol
3 fractional laser treatment-sessions with Monalisa Glide
Drug page: Clobetasol
Application of Clobetasol twice per week
Lichen Score
The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT
Time frame: 3 months
Lichen Score Follow up
Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)
Time frame: 15 months
Vulva assessment Scale
Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)
Time frame: 15 months
German Pelvic floor questionnaire
Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT
Time frame: 15 months
Plan to share: No
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Lichen Sclerosus et Atrophicus →
Kantonsspital Winterthur KSW