[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526489":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Kantonsspital Winterthur KSW","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Laser group","EXPERIMENTAL","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.",[13],"Device: Treatment with Monalisa Glide Laser",{"label":15,"type":16,"description":17,"interventionNames":18},"Clobetasol group","ACTIVE_COMPARATOR","Maintenance treatment with vulvar TCS (clobetasol) application 2x\u002Fweek. Instruction given at trial start and monthly check up for treatment control Daily local skin care with a drug free product of patients' choice.",[19],"Drug: Treatment with Clobetasol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Treatment with Monalisa Glide Laser","3 fractional laser treatment-sessions with Monalisa Glide",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Treatment with Clobetasol","Application of Clobetasol twice per week",[15],[33],{"name":34,"affiliation":35,"role":36},"Gesine Meili, MD","Clinic of obstetrics and gynecology","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Rebecca R Zachariah, MD","CONTACT","+41522663173","rebecca.zachariah@ksw.ch",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Susanne Forst","+41522663387","susanne.forst@ksw.ch",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Kantonsspital Winterthur","RECRUITING","Winterthur","Canton of Zurich","8401","Switzerland","CH",{"type":57,"coordinates":58},"Point",[59,60],8.72413,47.50564,{"lat":60,"lon":59},[63],{"name":64,"role":40,"phone":41,"phoneExt":26,"email":42},"Rebecca Zachariah, MD",{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100526489","comparison-of-laser-treatment-with-clobetasol-therapy-in-patients-with-lichen-sclerosus-100526489",false,"NCT06135402","Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus","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","Inclusion Criteria:\n\n* Pre- or postmenopausal\n* 12 weeks of continuous topical clobetasol treatment completed.\n* Written informed consent\n* German speaking (Study information and IC available only in German)\n\nExclusion Criteria:\n\n* Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use\n* Contraindication for the use of topic clobetasol\n* History of vulva laser\n* Immune-suppression\n* Pregnancy or planned pregnancy, breast feeding.\n* Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.\n* History of vulvar or pelvic radiation therapy\n* Uncertain vulvar findings, which require a biopsy.\n* Acute vulvitis, especially recurrent genital herpes\n* History of vaginal mesh implantation within 6 months preceding this study\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation\n* Previous enrolment into the current investigation\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons","FEMALE","18 Years",{"count":77,"type":78},120,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84],"Lichen Sclerosus","2025-09-18",{"date":87,"type":88},"2025-09-23","ACTUAL",{"date":90,"type":88},"2023-11-10",{"date":92,"type":78},"2027-11-01",{"name":5,"class":6},1]