Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus
NCT ID: NCT06135402
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-11-10
2027-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laser group
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 with Monalisa Glide Laser
3 fractional laser treatment-sessions with Monalisa Glide
Clobetasol group
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 with Clobetasol
Application of Clobetasol twice per week
Interventions
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Treatment with Monalisa Glide Laser
3 fractional laser treatment-sessions with Monalisa Glide
Treatment with Clobetasol
Application of Clobetasol twice per week
Eligibility Criteria
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Inclusion Criteria
* 12 weeks of continuous topical clobetasol treatment completed.
* Written informed consent
* German speaking (Study information and IC available only in German)
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Kantonsspital Winterthur KSW
OTHER
Responsible Party
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Principal Investigators
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Gesine Meili, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic of obstetrics and gynecology
Locations
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Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Laser-Lichen
Identifier Type: -
Identifier Source: org_study_id
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