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Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy

Study acronym: VVA PAP POPQ
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge. In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
Trial Details
NCT Number NCT07024667
Lead Sponsor Hillel Yaffe Medical Center
Conditions
(from sponsor)
Vulvar Atrophy, Vaginal Atrophy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov