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

ConditionsSjogren Syndrome Sjogren Disease Primary Sjogren Syndrome

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age30-65

SponsorUniversity of Sao Paulo General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Fractional CO2 laser (vaginal)
Device
Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: SjD with sicca vagintis complaints treated with vaginal fractional CO2 laserExperimental treatment 1 intervention

Group B: SjD with sicca vagintis complaints treated with topical promestrieneActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Four and six months

Secondary outcomes

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

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.

Time frame

Four and six months

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

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.

Time frame

Four and six months

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

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.

Time frame

Four and six months

Visual analogue scale (VAS) of vaginal dryness symptoms

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.

Time frame

Four and six months

Other outcomes

Histological analysis of vaginal wall biopsies before and after treatment

To evaluate the improvement of histological parameters in the tissue samples from vaginal wall biopsies before and after treatment in the two arms of the study. An experienced pathologist will blindly evaluate the tissue samples from vaginal wall biopsies before and after interventions in both study arms. This pathologist will report their subjective assessment of improvement (increase) (yes or no) in epithelial thickness, collagen fibers (percentage of collagen types I and III), and/or microvascularization (weak, moderate and intense).

Time frame

Six months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

Source ClinicalTrials.gov

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