Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the T… (NCT07024667) | Clinical Trial Compass
RecruitingNot Applicable
Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
Israel20 participantsStarted 2022-09-02
Plain-language 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.
Who can participate
Age range45 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Female 45-75 years of age, at the time of enrolment.
✓. Provided written informed consent.
✓. Spontaneous induced menopause as defined by one of the followings:
✓. One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded.
✓. Characteristic atrophic changes (see above) on gynaecological examination.
✓. Normal Papanicolaou (PAP) smear test from the last 3-5 years: if needed and as indicated according to the Israeli guidelines.
✓. Negative urine analysis test - urine stick.
✓. Asymptomatic for bacterial or fungal vaginitis.
Exclusion criteria
✕. Vaginal Health Index Score (VHIS) \< 5.
✕. Active genital infection.
What they're measuring
1
To evaluate the efficacy of Pixel CO2 laser (FemiLift™) for the treatment of VVA via the patient symptoms and complaints.
Timeframe: Two years
2
To evaluate gene expression following the FemiLiftTM treatment