Radiofrequency plus steroid cream versus steroid cream alone for vulvar lichen sclerosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized study enrolling women aged 18–49 with biopsy-confirmed vulvar lichen sclerosus who are assigned to either topical high‑potency corticosteroid alone or the same steroid regimen plus four sessions of dynamic quadripolar radiofrequency (DQRF). DQRF is delivered with a small vulvar applicator in four sessions at two‑week intervals starting two weeks after corticosteroid initiation. Outcomes include clinician-rated clinical severity scores, standardized photo documentation, multiple patient-reported outcome measures (pruritus, pain, VQLI, SF-12, FSFI), and safety monitoring with follow-up at 3, 6, and 12 months. Tissue-level changes by histology, elastin histochemistry, and immunohistochemistry (estrogen/androgen receptors, SOD2) will be measured in a subset of 10 patients per group before treatment and at 3 months after completion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnancy or lactation;
* Malignancy at the time of treatment or during any period of follow-up;
* 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 (such as HIV/AIDS) or use of immunosuppressive medications;
* Psychiatric disorders or communication difficulties that may interfere with study participation or compliance.

Where it's running

• National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: 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
• Study coordinator: Khava Balashova, MD, Obstetrics and Gynecology
• Email: Hava199@mail.ru
• Phone: +79251864388

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Methotrexate treatment for severe vulvar lichen sclerosus

  This trial will try methotrexate to reduce symptoms and prevent further scarring in women with severe vulvar lichen sclerosus who have not improved with high‑potency topical steroids.

  Recruiting Phase 2 Clinica Dermatologica Arbache ltda · São José dos Campos, São Paulo · NCT07352917

• Clobetasol ointment versus fractional CO2 laser for vulvar lichen sclerosus

  We are testing whether clobetasol ointment or fractional CO2 laser works better to reduce inflammation and symptoms in women with biopsy-confirmed vulvar lichen sclerosus who have not used topical corticosteroids.

  Recruiting Universidade Federal do Rio de Janeiro · Rio de Janeiro, Rio de Janeiro · NCT07240519

• Using StrataMGT to reduce symptoms of vulvar lichen sclerosus

  This study is testing if a new treatment called StrataMGT can help women with vulvar lichen sclerosus feel better and improve their quality of life.

  Recruiting at 3 sites Phase 1 Center for Vulvovaginal Disorders · Washington D.C., District of Columbia and 2 other locations · NCT06662942

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.