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

NCT07153276 | Recruiting Phase 4

• 1 other identifier: 67377523.3.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren Syndrome; Sjogren Disease; Primary Sjogren Syndrome

Keywords

Sjogren syndrome; vaginal dryness; vaginitis sicca; vaginal fractional CO2 laser; promestriene

Outcome Measures

Primary Outcomes (1)

• Vaginal Health Index (VHI)

  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.

  Four and six months

Secondary Outcomes (7)

• 6-Item version of the Female Sexual Function Index (FSFI)

  Four and six months

• Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)

  Four and six months

• International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

  Four and six months

• Visual analogue scale (VAS) of vaginal dryness symptoms

  Four and six months

• Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms

  Six months

Other Outcomes (1)

• Histological analysis of vaginal wall biopsies before and after treatment

  Six months

Study Arms (2)

SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser

EXPERIMENTAL

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

Device: Fractional CO2 laser (vaginal)

SjD with sicca vagintis complaints treated with topical promestriene

ACTIVE COMPARATOR

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

Drug: Promestriene Vaginal

Interventions

Fractional CO2 laser (vaginal) DEVICE

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

SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser

Promestriene Vaginal 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.

SjD with sicca vagintis complaints treated with topical promestriene

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Eloisa Bonfa, Full prof.

CONTACT

+55 11 30617492; eloisa.bonfa@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 3, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): September 27, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)