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

TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY

This trial will test whether monthly vaginal fractional CO2 laser or ongoing topical promestriene helps women with Sjögren's disease who have vaginal dryness.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 30 Years to 65 Years
• Sex: Female
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07153276 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adult women diagnosed with Sjögren's disease by ACR/EULAR criteria, with controlled systemic activity (ESSDAI < 5) and current complaints of vaginal dryness who can attend the study site and provide informed consent.

Not a fit: Patients with active systemic disease, other concurrent autoimmune rheumatic conditions, a history of hormone-sensitive cancers or thromboembolic events, or significant organ failure were excluded and therefore may not be eligible to receive benefit from this study.

Why it matters

Potential benefit: If successful, the intervention could reduce vaginal dryness symptoms and improve sexual health and quality of life for women with Sjögren's disease.

How similar studies have performed: Vaginal CO2 laser and topical promestriene have shown symptom improvement in menopausal urogenital syndrome, but their specific effectiveness in Sjögren's disease has been relatively untested.

Eligibility criteria

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 this trial is running

São Paulo, São Paulo

• University of Sao Paulo General Hospital — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Eloisa Bonfa, Full prof.

Conditions Sjogren Syndrome; Sjogren Disease; Primary Sjogren Syndrome; Sjogren syndrome; vaginal dryness; vaginitis sicca; vaginal fractional CO2 laser; promestriene