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

NCT ID: NCT07153276

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-19
• Study Completion Date: 2029-12-30

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 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.

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 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.

Conditions

Sjogren Syndrome; Sjogren Disease; Primary Sjogren Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser

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

Group Type: EXPERIMENTAL

Fractional CO2 laser (vaginal)

Intervention Type: DEVICE

Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.

SjD with sicca vagintis complaints treated with topical promestriene

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

Group Type: ACTIVE_COMPARATOR

Promestriene Vaginal

Intervention Type: DRUG

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.

Interventions

Fractional CO2 laser (vaginal)

Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.

Intervention Type: DEVICE

Promestriene Vaginal

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Eloisa Bonfa, Full prof.

Role: CONTACT

eloisa.bonfa@hc.fm.usp.br

+55 11 30617492

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Other Identifiers

67377523.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id