Actively Recruiting
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids 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
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Histologically confirmed diagnosis of vulvar lichen sclerosus
- Provided written informed consent to participate in the study
You will not qualify if you...
- Pregnancy or breastfeeding
- Current malignancy or malignancy during follow-up
- Postmenopausal status
- Severe uncontrolled somatic diseases
- Sexually transmitted infections including hepatitis B, hepatitis C, and syphilis
- Presence of a cardiac pacemaker or metal-containing intrauterine device (IUD)
- Treatment with other high-energy-based therapies within the last 6 months
- Use of topical corticosteroids within the last 3 months
- Immunosuppression including HIV/AIDS or use of immunosuppressive drugs
- Psychiatric disorders or communication difficulties interfering with participation or compliance
AI-Screening
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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
CONTACT
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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