Lichen Sclerosus Clinical Trials

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Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
RECRUITING
Moscow
Contact Information
Primary
Khava Balashova, MD, Obstetrics and Gynecology
Hava199@mail.ru
+79251864388
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2027-02
Participants
Target number of participants: 68
Treatments
Experimental: Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids
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.
Active_comparator: Topical Corticosteroid Monotherapy
Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.
Related Therapeutic Areas
Sponsors
Leads: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

This content was sourced from clinicaltrials.gov