Vulva; Atrophy
Conditions
Keywords
Vulva, Atrophy, Co2, Vulvo-vaginal, Microbiome, Modulation, Laser, Theraphy, Collagen, Collagen Cream
Brief summary
This study evaluated a new treatment for postmenopausal women suffering from vulvo-vaginal atrophy (VVA), a condition that causes dryness, burning, and pain. Researchers tested whether combining CO₂ laser therapy with a collagen-based cream could improve symptoms more effectively than laser treatment alone.
Detailed description
Sixty women participated in the study. Results showed that the combination treatment provided greater relief from discomfort and helped restore vaginal health, with fewer side effects. This approach may offer a safe and effective alternative for women who cannot use hormone-based therapies.
Interventions
DEVICESmartXide2 treatment plus the application of Palingen cream
Patients will be randomized into two groups: one called the "control" group, in which patients will receive only the SmartXide2 treatment, and the second called "PALINGEN," in which patients will receive SmartXide2 treatment plus the application of Palingen cream.
DEVICELaser Therapy Only (Control Group)
Participants receive fractional CO₂ laser therapy according to the standard protocol for vulvo-vaginal atrophy. No additional topical treatment is applied. Laser sessions are performed at baseline (Day 0), Day 30, and Day 60. Follow-up visits include clinical evaluation and microbiome sampling at each time point.
Sponsors
Institute for Social Security, Republic of San Marino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an interventional, single-center study. Patients will be randomized into two groups: one called the "control" group, in which patients will receive only the SmartXide2 treatment, and the second called "PALINGEN," in which patients will receive SmartXide2 treatment plus the application of Palingen cream. It should be noted that both SmartXide2 and Palingen cream (and their combination) have been part of the standard clinical practice at the experimental center for several years. The effectiveness of the combined action of the two treatments will be evaluated by analyzing the associated symptoms using a Visual Analogue Scale (VAS) from 1 to 10 for each symptom, as well as through analysis of the vaginal microbiome. Additionally, all adverse events will be recorded.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women with absence of menstrual cycle for at least 12 months, diagnosed with vulvovaginal atrophy (VVA) and presenting with related symptoms such as dryness, introital and deep dyspareunia, bleeding during intercourse, itching, or burning related to the severity of VVA, whether spontaneous or drug-induced (radio- or chemotherapy), either with a single symptom or a combination thereof. * Age between 35 and 75 years; * Patients unresponsive or dissatisfied with previous topical estrogen therapy, or presenting contraindications to the use of local and/or systemic estrogens. * Previous negative Pap test performed within 3 years prior to study enrollment.
Exclusion criteria
* • Pregnancy or breastfeeding; * Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva; * Presence of active genital and/or urinary tract infection; * Relative or absolute dermatological contraindications to laser use; * Ongoing hormonal therapy (systemic or local); * Neurological and/or psychiatric disorders; * Chronic systemic autoimmune or metabolic diseases; * Refusal to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms | Outcome: Improvement in symptoms associated with vulvo-vaginal atrophy (VVA) Assessment Tool: Visual Analogue Scale (VAS) Time Frame: Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second | Assessed after 30 and 60 days of treatment using the Visual Analogue Scale (VAS). The VAS was used to quantify symptom intensity such as burning, dryness, itching, dyspareunia, and pain. Improvement was measured as the difference in VAS scores before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Microbiome Composition | Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second month / end of treatment | Analysis before and after 30 and 60 days of treatment. Parameters included: Biodiversity (Observed Operational Taxonomic Units, OTUs). Relative abundance of Lactobacillus genus and its species (L. crispatus, L. iners, etc.). Relative amounts of pathogenic bacteria (Gardnerella vaginalis, Atopobium vaginae, etc.). |
| Symptom improvement at intermediate time points | Baseline → Visit 1 (Day 30) Baseline → Visit 2 (Day 60) | Comparison of VAS scores at Visit 1 (30 days) and Visit 2 (60 days) against baseline. |
| Adverse Events Monitoring | Continuous from first laser session (Day 0) through 30 days and 60 days post-treatment | Frequency and severity of side effects (e.g., redness, mild bleeding, burning, swelling) were recorded throughout the study. |
Countries
San Marino
Outcome results
None listed