Vaginal fractional CO2 laser versus topical promestriene for vaginal dryness in Sjögren's disease

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 single-center, randomized 6-month trial that will enroll 60 women with Sjögren's disease and complaints of vaginal dryness and assign them 1:1 to receive either three monthly sessions of vaginal fractional CO2 laser or a six-month topical promestriene regimen. Eligible participants have controlled systemic disease activity and may be pre- or postmenopausal. Outcomes will compare symptom changes and related quality-of-life measures between the two groups over the study period. Treatments and follow-up visits will take place at the University of São Paulo General Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Sao Paulo General Hospital
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Eloisa Bonfa, Full prof.
• Email: eloisa.bonfa@hc.fm.usp.br
• Phone: +55 11 30617492

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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.