UOC di Ostetricia e Ginecologia, Ospedale di Stato della Repubblica di San Marino, Istituto per la Sicurezza Sociale (ISS)
San Marino, Borgo Maggiore, 47893
NCT Number: NCT07246616
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.
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Notify Me35 year–75 year
Female
Interventional
Not applicable
San Marino, Borgo Maggiore, 47893
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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: 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.).
Time frame: 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.
Time frame: 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.
Institute for Social Security, Republic of San Marino
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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