Laser vs. steroid cream: new hope for vulvar lichen sclerosus?
NCT ID NCT06135402
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares a laser treatment (Monalisa Glide) to a standard steroid cream (clobetasol) for keeping vulvar lichen sclerosus under control. 120 women who have already completed 12 weeks of steroid treatment will receive either three laser sessions or continue using the cream twice a week. The goal is to see if the laser works as well as the steroid for maintaining symptom control over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Monalisa Glide laser (device) and clobetasol propionate cream (drug)
- What this could lead to
- If successful, this could offer a non-steroid maintenance option for vulvar lichen sclerosus, reducing long-term steroid use.
- What could go wrong
- This is a small, single-center trial comparing to an active control, not placebo. The laser may not be as effective as standard steroid treatment, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kantonsspital Winterthur
RECRUITINGWinterthur, Canton of Zurich, 8401, Switzerland
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