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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-75
SponsorHillel Yaffe Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Female 45-75 years of age, at the time of enrolment.

Provided written informed consent.

Amenorrhea of ≥12 months

After bilateral oophorectomy

Disqualifiers

Vaginal Health Index Score (VHIS) < 5.

Active genital infection.

Vaginal bleeding which did not underwent evaluation.

Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.

Trial design

Treatments tested in this trial

  • Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators