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New combo treatment tested for painful skin condition

NCT ID NCT07363733

Disease control Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a special radiofrequency treatment to standard steroid cream works better than steroid cream alone for women with vulvar lichen sclerosus, a chronic skin condition causing itching, pain, and discomfort. About 68 women of reproductive age will be randomly assigned to one of two groups and followed for a year. The goal is to see if the combination improves symptoms and quality of life more effectively.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

vulvar lichen sclerosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vulvar lichen sclerosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Moscow, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.