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Laser or cream? new study tackles vaginal dryness in Sjögren's

NCT ID NCT07153276

Symptom relief Sponsor: University of Sao Paulo General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two treatments for vaginal dryness in women with Sjögren's disease: a fractional CO2 laser applied monthly for three months, and a topical promestriene cream used for six months. Sixty participants will be randomly assigned to one of the two groups. The goal is to see which treatment better improves vaginal health and sexual function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fractional CO2 laser (vaginal) and promestriene vaginal capsules
What this could lead to
If successful, this could provide effective, non-hormonal or hormonal treatment options for vaginal dryness in Sjögren's disease, improving quality of life and sexual health.
What could go wrong
This is a small, early-phase study (60 participants) comparing two treatments, so results may not apply to all patients. Both treatments have known risks like discomfort or irritation, and the laser is not yet proven for this condition.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

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

Started

Feb 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

30 to 65 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: * Diagnosis of SjD according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (2016). * Controlled systemic disease activity \[EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)\] \< 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg/day. * Present complaints of vaginal dryness upon study entry. * Agreeing to participate in the protocol according to the informed consent form signed before study inclusion. Exclusion Criteria: * History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure. * Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease. * Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

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

Primary Sjogren syndrome Sjogren disease Sjogren syndrome

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

  • University of Sao Paulo General Hospital

    RECRUITING

    São Paulo, São Paulo, Brazil

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