Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus (NCT03063684) | Clinical Trial Compass
CompletedNot Applicable
Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus
Israel16 participantsStarted 2017-09-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Vaginal Atrophy - Inclusion Criteria
* Menopause for more than one year
* One or more of the following symptoms: sensation of dryness, itch, irritation, burning, discomfort, dysuria, dyspareunia
* Characteristic atrophic changes on gynecological examination
* Laboratory workup: pH \>4.5, characteristic microscopic smear (increased number of para-basal cells)
* Normal Pap-smear within 12 months
* Negative vaginal culture for fungi or relevant bacteria
* Negative test for STD pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas)
Exclusion Criteria
* Genital skin disease
* Active infection
* Pelvic organs prolapse above grade 2
* Previous surgery for pelvic organs prolapse
* Use of systemic or local hormonal preparations during 6 months preceding the study treatment
* History of malignant diseases
* Undiagnosed vaginal bleeding
* Use of analgesics or antidepressants
* Use of anticoagulants
Lichen Sclerosus Inclusion Criteria
* Age 18-80
* Biopsy demonstrates characteristic changes for lichen sclerosus
* One or more of the following symptoms: sensation of dryness, itch, irritation, burning, discomfort.
* Characteristic changes for lichen sclerosus on gynecological examination
* Negative vaginal culture for fungi or relevant bacteria
* Negative test for STD pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas)
Exclusion Criteria
* Use of steroid-containing creams for the vulvar region two months preceding recruitment
* Additional genital skin d…
What they're measuring
1
Change from baseline of vaginal health index score