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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
UOC di Ostetricia e Ginecologia, Ospedale di Stato della Repubblica di San Marino, Istituto per la Sicurezza Sociale (ISS)
San Marino, Borgo Maggiore, San Marino
Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms
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.
Time frame: 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
Vaginal Microbiome Composition
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.).
Time frame: Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second month / end of treatment
Symptom improvement at intermediate time points
Comparison of VAS scores at Visit 1 (30 days) and Visit 2 (60 days) against baseline.
Time frame: Baseline → Visit 1 (Day 30) Baseline → Visit 2 (Day 60)
Adverse Events Monitoring
Frequency and severity of side effects (e.g., redness, mild bleeding, burning, swelling) were recorded throughout the study.
Time frame: Continuous from first laser session (Day 0) through 30 days and 60 days post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.