Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:35 PM
Study NCT ID:
NCT07363733
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007724', 'term': 'Vulvar Lichen Sclerosus'}], 'ancestors': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical severity of vulvar lichen sclerosus', 'timeFrame': 'Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.', 'description': 'Change from baseline in patient-reported symptom intensity using validated questionnaire (Numeric Rating Scale (NRS) for pruritus, vulvar pain, burning, dryness and dyspareunia).'}], 'secondaryOutcomes': [{'measure': 'Changes in Patient-Reported Outcomes', 'timeFrame': 'Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.', 'description': 'Change from baseline in general health-related quality of life assessed using the Short Form-12 Health Survey (SF-12). Change from baseline in sexual function assessed using the Female Sexual Function Index (FSFI).'}, {'measure': 'Tissue-Level Biomarkers', 'timeFrame': 'Before treatment (baseline) and at 3 months after completion of therapy.', 'description': 'Change from baseline in estrogen and androgen receptor expression (percentage) in vulvar tissue assessed by immunohistochemistry in a subset of 10 patients per group. Change from baseline in superoxide dismutase (SOD) expression (percentage) in vulvar tissue assessed by immunohistochemistry in a subset of 10 patients per group. Change from baseline in elastin fiber staining intensity (percentage) and distribution in vulvar tissue assessed by histochemical analysis in a subset of 10 patients per group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vulvar lichen sclerosus', 'Dynamic Quadripolar RadioFrequency', 'Glucocorticoids', 'Immunohistochemistry', 'Quality of Life', 'Female Sexual Function'], 'conditions': ['Vulvar Lichen Sclerosus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a prospective, randomized study conducted in women reproductive age with vulvar lichen sclerosus. Computer-generated randomization using an electronic spreadsheet will be used by investigators to assign participants to study groups.\n\nStudy groups Group 1: 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. DQRF therapy will be administered using a small vulvar applicator in a total of four sessions, performed at two-week intervals.\n\nGroup 2: topical high-potency corticosteroid therapy according to a standardized regimen.\n\nStudy assessments Clinical assessment At baseline and each follow-up visit, participants will undergo standardized vulvar examination with documentation of objective signs (skin color changes, sclerosis, fissures, erosions, scarring and architectural changes) and symptom severity. Clinical severity will be assessed using a structured clinician-rated vulvar lichen sclerosus severity score. Standardized photo documentation will be performed.\n\nPatient-reported outcome measures\n\nPatient-reported outcomes will be assessed using validated questionnaires:\n\n* Numeric Rating Scale (NRS) for pruritus, vulvar pain, burning, dryness and dyspareunia;\n* Vulvar Quality of Life Index (VQLI);\n* Short Form-12 Health Survey (SF-12);\n* Female Sexual Function Index (FSFI). Histological and tissue-level assessment\n\nHistochemical and immunohistochemical analyses will be performed in a subset of 10 patients per group. Vulvar punch biopsy specimens will be obtained before initiation of therapy and after completion of treatment for:\n\n* immunohistochemical analysis of estrogen receptors, androgen receptors and superoxide dismutase 2 (SOD2) expression;\n* histochemical assessment of elastin fiber staining intensity and distribution using a standardized elastin stain, with semi-quantitative grading and/or digital image analysis.\n\nSafety assessment Adverse events related to topical therapy, radiofrequency treatment will be recorded throughout the study.\n\nFollow-up period Participants will be followed longitudinally before the treatment, at the end of treatment, and at 3, 6, and 12 months after completion of therapy to evaluate short-term response, durability of clinical improvement, and disease recurrence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/AIDS) or use of immunosuppressive medications;\n* Psychiatric disorders or communication difficulties that may interfere with study participation or compliance.'}, 'identificationModule': {'nctId': 'NCT07363733', 'briefTitle': 'Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare'}, 'officialTitle': 'Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus', 'orgStudyIdInfo': {'id': 'DQRF10.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids', 'description': '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.', 'interventionNames': ['Device: Dynamic Quadripolar Radiofrequency (DQRF)', 'Drug: Topical high-potency corticosteroid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Corticosteroid Monotherapy', 'description': 'Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.', 'interventionNames': ['Drug: Topical high-potency corticosteroid']}], 'interventions': [{'name': 'Dynamic Quadripolar Radiofrequency (DQRF)', 'type': 'DEVICE', 'description': 'Dynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals.', 'armGroupLabels': ['Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids']}, {'name': 'Topical high-potency corticosteroid', 'type': 'DRUG', 'description': 'Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.', 'armGroupLabels': ['Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids', 'Topical Corticosteroid Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Khava Balashova, MD, Obstetrics and Gynecology', 'role': 'CONTACT', 'email': 'Hava199@mail.ru', 'phone': '+79251864388'}, {'name': 'Khava Balashova, MD, Obstetrics and Gynecology', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Khava Balashova, MD, Obstetrics and Gynecology', 'role': 'CONTACT', 'email': 'Hava199@mail.ru', 'phone': '+79251864388'}], 'overallOfficials': [{'name': 'Khava Balashova, MD, Obstetrics and Gynecology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patients data is available upon request from the authors with no identifiable information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}