TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE
Recruiting
Phase 4
Interventional Study
Sjogren Syndrome
Sjogren Disease
Primary Sjogren Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 – 65
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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About This Trial
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 disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation…
Trial Locations
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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 gluco…
Contacts