Last updated 4 months ago
TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE
60 patients around the world
Available in Brazil
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 patients for the intervention group - vaginal fractional CO2 laser - and 30 patients for the comparator group - topical promestriene. Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months. Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.
University of Sao Paulo General Hospital
1Research sites
60Patients around the world
This study is for people with
Rare diseases
Sjogren's syndrome
Requirements for the patient
To 65 Years
Female
Medical requirements
- 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.
- 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.
Sites
Hospital das Clínicas da FMUSP - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Recruiting
StudyVaLS
SponsorUniversity of Sao Paulo General Hospital
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
To 65 YearsFemale
Unique study IDclinicaltrials.gov
NCT07153276
