Status:
NOT_YET_RECRUITING
TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Sjogren Syndrome
Sjogren Disease
Eligibility:
FEMALE
30-65 years
Phase:
PHASE4
Brief Summary
Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The di...
Detailed Description
This is a prospective randomized study lasting 6 months. Sixty SjD patients (pre- or post-menopausal) and with complaints of vaginal dryness will be included and randomized into two groups: 30 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07153276
Start Date
January 19 2026
End Date
December 30 2029
Last Update
October 3 2025
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