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

Not Applicable

Not yet recruiting

• Conditions: Sjogren Syndrome
• Interventions: Device: Fractional CO2 laser (vaginal); Drug: Promestriene Vaginal

• Registration Number: NCT07153276
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-11-07
• Primary Completion: 2029-01-12
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser	Fractional CO2 laser (vaginal)	Thirty SjD patients with vaginitis sicca symptoms allocated to the intervention group (vaginal fractional CO2 laser)
SjD with sicca vagintis complaints treated with topical promestriene	Promestriene Vaginal	Thirty SjD patients with vaginitis sicca symptoms allocated to the comparator group (topical promestriene)

Primary Outcome Measures

Name	Time	Method
Vaginal Health Index (VHI)	Four and six months	To assess the improvement in the Vaginal Health Index (VHI) after treatment compared to the patient's baseline status in both arms. This score ranges from 5 (minimum) to 25 (maximum) and higher values indicate better outcomes.
Visual analogue scale (VAS) of vaginal dryness symptoms	Four and six months	To assess the improvement in the visual analogue scale (VAS) of vaginal dryness symptoms after treatment compared to the patient's baseline status in both arms. This scale ranges from 0 (minimum) to 10 (maximum) and higher values indicate worse outcomes.
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	Four and six months	To assess the improvement in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 21 (maximum) and higher values indicate worse outcomes.

Secondary Outcome Measures

Name	Time	Method
6-Item version of the Female Sexual Function Index (FSFI)	Four and six months	To assess the improvement in the 6-item version of the Female Sexual Function Index (FSFI) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 30 (maximum) and higher values indicate better outcomes.
Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)	Four and six months	To assess the improvement in the Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 96 (maximum) and higher values indicate worse outcomes.
Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms	Six months	To assess the possible persistence of the beneficial effects of laser therapy after the end of applications (in the medium term). This assessment will be performed by observing improvements on the visual analogue scale (VAS) of vaginal dryness symptoms after treatment compared to the patient's baseline status in both arms. This scale ranges from 0 (minimum) to 10 (maximum) and higher values indicate worse outcomes.
Incidence of treatment-emergent adverse events (safety and tolerability)	One month, two months, three months, four months, five months, six months	To assess the incidence of treatment-emergent adverse events (as a percentage) in the two arms of the study.
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (safety and tolerability)	Four and six months	To assess the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after treatment compared to the patient's baseline status in both study arms. This score ranges from 0 (minimum) to 123 (maximum) and higher values indicate worse outcomes.