Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus
Vaginal Atrophy, Lichen Sclerosus
About this trial
This is an interventional basic science trial for Vaginal Atrophy
Eligibility Criteria
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 disease
- Active infection
- History of malignant diseases
- Use of analgesics or antidepressants
- Use of anticoagulants
- Pregnancy or planning pregnancy during the study
- Systemic treatment with immuno-modulatory drugs
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Vaginal atrophy
Lichen sclerosus
With decreasing estrogen levels occurring following menopause, changes of the vaginal mucosa appear: it becomes thin and pale and loses its elasticity. The blood supply decreases, normal secretion is reduced, the epithelial cells do not undergo the normal differentiation process, the bacterial population changes with loss of lactobacilli and pH increases. These changes are associated with morphological and histological changes, manifested, among other findings, by alterations in the collagen composition, loss of the trabecular organization of collagen and reduced amount of elastic fibers. Women with reduced vaginal estrogen content may report dryness, itching, discomfort, burning sensation during micturition, pain and dyspareunia. These changes are reversible: topical or systemic estrogen change the vaginal mucosa's characteristics and may also alleviate complaints arising from estrogen deficiency. The intervention is 3 treatments with fractional / Pixel CO2 Laser
Lichen sclerosus is a chronic cutaneous disease involving the vulvar and peri-anal skin. The involved skin becomes thin and white, with frequently present bruises or petechiae and anatomic changes. Lichen sclerosus is thought to be an auto-immune disorder and its most frequent signs are itching, irritation or burning. The discoloration may involve the entire vulvar and peri-anal area (sometimes having the form of an "8" or a "keyhole" surrounding the vulva and anus) or appear as separated spots of various sizes occupying only part of the skin. At advanced stages of lichen sclerosus, scarring may appear, with loss of the labia minor and adhesions which may entirely cover the clitoris. The treatment is of topical steroid. Lichen sclerosus is a chronic disorder, and even with good treatment, in a certain proportion of cases the skin does not return to its original appearance. The intervention is 3 treatments with fractional / Pixel CO2 Laser