Actively Recruiting
Randomized Clinical Trial of Combined Dynamic Quadripolar Radiofrequency Therapy Versus Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus
Led by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Updated on 2026-01-23
68
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for vulvar lichen sclerosus in women of reproductive age. This prospective, randomized study compares the effects of combined dynamic quadripolar radiofrequency (DQRF) therapy plus topical high-potency corticosteroids with topical corticosteroid therapy alone. The study aims to assess clinical outcomes, patient-reported symptoms, and tissue-level changes in vulvar skin using histology and immunohistochemistry. Safety will be monitored throughout the study period. Participants will be randomly assigned to one of two groups. One group will receive topical corticosteroid therapy following a standardized regimen, followed by four sessions of DQRF therapy every two weeks starting two weeks after corticosteroid initiation. The other group will receive only the topical corticosteroid treatment. Tissue biopsies will be taken from a subset of participants before treatment and three months after treatment completion to analyze estrogen and androgen receptor expression, elastin fibers, and superoxide dismutase 2 (SOD2) levels. During the study, participants will have regular clinical assessments at baseline, end of treatment, and at 3, 6, and 12 months after treatment completion. These visits include vulvar examinations, documentation of skin changes and symptoms, and patient questionnaires on itching, pain, burning, dryness, sexual function, and quality of life. Safety and adverse events related to treatments will be tracked throughout. The main outcome measured is the change in clinical severity of vulvar lichen sclerosus over time, alongside patient-reported outcomes and tissue biomarker changes.
CONDITIONS
Brief Title
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 49 years (women of reproductive age)
- Histologically confirmed diagnosis of vulvar lichen sclerosus
- Written informed consent to participate in the study
You will not qualify if you...
- Pregnancy or lactation
- Malignancy at the time of treatment or during any follow-up period
- Postmenopausal status
- Severe decompensated somatic disease
- Sexually transmitted infections, including hepatitis B, hepatitis C, and syphilis
- Presence of a cardiac pacemaker or metal-containing intrauterine device (IUD)
- History of treatment with other high-energy-based modalities within the last 6 months
- Use of topical corticosteroids within the last 3 months
- Immunosuppression, including immunodeficiency disorders or use of immunosuppressive medications
- Psychiatric disorders or communication difficulties that may interfere with participation or compliance
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 weeks including corticosteroid and radiofrequency sessions
Participants receive topical high-potency corticosteroid therapy according to a standardized regimen. Participants in one group also receive Dynamic Quadripolar Radiofrequency (DQRF) therapy starting 2 weeks after corticosteroid initiation, consisting of four sessions at two-week intervals using a vulvar applicator.
5 visits (1 baseline and 4 treatment sessions every 2 weeks)
Duration - Up to 12 months after completion of therapy
Participants are followed longitudinally to evaluate clinical response, durability of improvement, and disease recurrence with clinical assessments and patient-reported outcomes.
4 visits at end of treatment, 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
Moscow, Russia
Actively Recruiting
Research Team
K
Khava Balashova, MD, Obstetrics and Gynecology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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