NCT07024667

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hillel Yaffe Medical Center · Other Government
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vulvar Atrophy
• Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)	Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)

Timeline

• Start date: 2022-09-02
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: Israel