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临床试验/NCT03063684
NCT03063684已完成不适用

Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Change from baseline of vaginal health index score

研究概览

简要总结

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.

详细描述

Many studies have been published recently describing the use of a fractional/pixel CO2 laser for the treatment of various disorders of the vulva and the vagina, such as atrophy due to estrogen deficiency, urinary stress incontinence, skin diseases (lichen sclerosus) and more.

The results of the studies that investigated this technology in relation to vaginal atrophy and urinary stress incontinence have shown improvement in symptoms after a series of only 3 treatments.

The proposed effect of the fractional CO2 laser is based on studies performed on non-genital tissues [Daffon, Capon], which demonstrated changes in the connective tissue and proliferation of fibroblasts, as well as formation of collagen and elastic fibers. The suggested explanation is based on the theory that heat shock proteins are involved in the process and arise due to thermal tissue damage, and this in turn activate tissue cytokines, growth factors and fibroblasts. These theories have not been proven for vulvar and vaginal tissues, and except for the demonstration of histologic and morphologic changes in the irradiated tissues [Salvatore, Menopause 2015], the cellular mechanism of action and the nature of the process mediating the changes in uro-genital tissues has not yet been examined.

The technology known as fractional CO2 has been used for many years in dermatology and plastic surgery. In this method, the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2. The laser beam penetrates the tissue and causes minimal evaporation around each spot of the fractionated beams and release of heat only at the desired tissue depth. The method of energy transfer to tissues in tiny dots leads to the creation of various thermal effects in the focus of the beam, around the focus, and in the areas between these heat foci. Following the tissue irradiation, different processes occur: epithelial cell proliferation and thickening of the epithelial layer, migration and proliferation of endothelial cells, creation of neo-vasculature in the lamina propria, creation of collagen and elastic fibers, and accumulation of glycogen in the cells [Salvatore, Menopause 2015]. The result of these processes is improved tissue elasticity and plasticity as well as regeneration of the epidermis layer. Previous studies demonstrated that the effect of this treatment on the atrophic vagina is identical to long-term local estrogen treatment, with improved cytological index, improved lubrication, alteration of the vaginal flora, and reduced acidity to the level of "estrogenic" levels (approx. pH 4 -4.5) [Salvatore, Menopause, 2015;Perino; Gasper; Salvatore, Climacteric, 2015].

Considering the multitude of recently published articles presenting impressive clinical results, the investigators decided to examine the effects of the treatment with a fractional CO2 laser on the vaginal and vulvar tissue at a cellular level for two conditions: vaginal atrophy due to estrogen deficiency and lichen sclerosus. These two conditions were chosen due to the magnitude of recent publications dealing with clinical and histological improvement in these two pathological conditions following laser treatment. Understanding the cytological processes will enable the foundation of knowledge about the basic mechanism of action, and propose methods to improve the current therapeutic protocols. It will also enable the observation of the duration of the treatment effect, and the assessment of whether these changes are associated with undesired events, such as increased risk of malignant tissue transformation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Vaginal atrophy

Experimental

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

干预措施: Fractional / Pixel CO2 Laser (Device)

Lichen sclerosus

Experimental

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

干预措施: Fractional / Pixel CO2 Laser (Device)

结局指标

主要结局

Change from baseline of vaginal health index score

时间窗: T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months

Score of 1-15, which includes the following parameters: elasticity, fluid volume, pH, epithelial integrity, moisture.

次要结局

  • Change from baseline of Maturation Index(T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months)
  • Change from baseline of pH measurement(T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months)
  • Change from baseline of patient's symptoms(T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahinoam Lev-Sagie

MD

Hadassah Medical Organization

研究点 (1)

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