At a glance
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Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus
In Brief
A clinical study evaluating Fractional / Pixel CO2 Laser for Vaginal Atrophy and Lichen Sclerosus. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy and in vulvar lichen sclerosus by means of histological and immuno-histochemical characterization of the epithelial layers and markers of tissue aging. The tissue characterization will be performed by biopsies of the vaginal or vulvar tissue at three different points of time: prior to treatment, two weeks after the third and last treatment, and one year after the last treatment.
Study Details
Timeline
Interventions
The laser energy is transferred in a fractioned manner: the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2, so the laser rays hit the tissue in small spots. For gynecological applications, the treatment is performed by a transducer, which was specifically designed for vaginal application.