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Efficacy and Safety of CO₂ Laser Therapy Combined With Collagen Cream in Managing Vulvo-Vaginal Atrophy: A Randomized, Controlled Study on Symptom Relief and Microbiome Modulation

NCT07246616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Vulva; Atrophy

Interventions

DEVICE

SmartXide2 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.

DEVICE

Laser 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 & Collaborators

  • Institute for Social Security, Republic of San Marino

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-10-01
Completion
2024-10-31

Countries

  • San Marino

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246616 on ClinicalTrials.gov