[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620908":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids","EXPERIMENTAL","Participants receive topical high-potency corticosteroid therapy according to the standardized regimen, followed by combined Dynamic Quadripolar Radiofrequency (DQRF) therapy initiated 2 weeks after the start of corticosteroid treatment.",[13,14],"Device: Dynamic Quadripolar Radiofrequency (DQRF)","Drug: Topical high-potency corticosteroid",{"label":16,"type":17,"description":18,"interventionNames":19},"Topical Corticosteroid Monotherapy","ACTIVE_COMPARATOR","Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Dynamic Quadripolar Radiofrequency (DQRF)","Dynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Topical high-potency corticosteroid","Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.",[9,16],[33],{"name":34,"affiliation":35,"role":36},"Khava Balashova, MD, Obstetrics and Gynecology","National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+79251864388","Hava199@mail.ru",[43],{"facility":35,"status":44,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Moscow","Russia","RU",{"type":49,"coordinates":50},"Point",[51,52],37.61781,55.75204,{"lat":52,"lon":51},[55,56],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100620908","dynamic-quadripolar-radiofrequency-vs-topical-corticosteroids-in-women-with-vulvar-lichen-sclerosus-100620908",false,"NCT07363733","Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus","Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus","Inclusion Criteria:\n\n* Women aged 18 to 49 years (women of reproductive age);\n* Histologically confirmed diagnosis of vulvar lichen sclerosus;\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Malignancy at the time of treatment or during any period of follow-up;\n* Postmenopausal status;\n* Severe decompensated somatic disease;\n* Sexually transmitted infections, including hepatitis B, hepatitis C, and syphilis;\n* Presence of a cardiac pacemaker or metal-containing intrauterine device (IUD);\n* History of treatment with other high-energy-based modalities within the last 6 months;\n* Use of topical corticosteroids within the last 3 months;\n* Immunosuppression, including immunodeficiency disorders (such as HIV\u002FAIDS) or use of immunosuppressive medications;\n* Psychiatric disorders or communication difficulties that may interfere with study participation or compliance.","FEMALE","18 Years","49 Years",{"count":70,"type":71},68,"ESTIMATED","INTERVENTIONAL",[74],"NA","This is a prospective, randomized study in women of reproductive age with vulvar lichen sclerosus. Participants will be randomly assigned by investigators using a computer-generated sequence to receive either combined dynamic quadripolar radiofrequency (DQRF) plus topical corticosteroid therapy or topical high-potency corticosteroid therapy alone. Clinical outcomes, patient-reported outcomes and tissue-level changes evaluated by histology, elastin histochemistry, and immunohistochemistry for estrogen, androgen receptors and superoxide dismutase 2 (SOD2) will be assessed before and after treatment, and during follow-up at 3, 6, and 12 months. Safety will be monitored throughout the study. Histochemical and immunohistochemical analyses will be performed in a subset of 10 patients per group before the treatment and at 3 months after the completion of treatment.",[77],"Vulvar Lichen Sclerosus",[79,80,81,82,83,84],"vulvar lichen sclerosus","Dynamic Quadripolar RadioFrequency","Glucocorticoids","Immunohistochemistry","Quality of Life","Female Sexual Function","2026-01-14",{"date":87,"type":88},"2026-01-23","ACTUAL",{"date":90,"type":71},"2026-01",{"date":92,"type":71},"2027-02",{"name":5,"class":6},1]