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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 (VVA)
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.
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. The aim of the current study is to evaluate the effect of Pixel CO2 laser, (FemiLiftTM), for the treatment of VVA, on the clinical and molecular levels.
Age
45 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Hille Yaffe Medical Center
Hadera, Israel
Start Date
September 2, 2022
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
June 17, 2025
20
ESTIMATED participants
Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
DEVICE
Lead Sponsor
Hillel Yaffe Medical Center
NCT06900374
NCT07367061
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View ClinicalTrials.gov Terms and ConditionsNCT04081805