TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE (VaLS)

University of Sao Paulo General Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Sjogren Syndrome; Primary Sjogren Syndrome; Sjogren Disease

Treatments: Drug: Promestriene Vaginal; Device: Fractional CO2 laser (vaginal)

Study type: Interventional

Funder types: Other

Identifiers

NCT07153276

67377523.3.0000.0068

Details and patient eligibility

About

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, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency/incontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.

Full 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 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser

Experimental group

Description:

Thirty SjD patients with vaginitis sicca symptoms allocated to the intervention group (vaginal fractional CO2 laser)

Treatment:

Device: Fractional CO2 laser (vaginal)

SjD with sicca vagintis complaints treated with topical promestriene

Active Comparator group

Description:

Thirty SjD patients with vaginitis sicca symptoms allocated to the comparator group (topical promestriene)

Treatment:

Drug: Promestriene Vaginal