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临床试验/NCT03075046
NCT03075046Unknown不适用

Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial

Centro de Atenção ao Assoalho Pélvico1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode

研究概览

简要总结

Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an important health issue due to the high incidence and difficulties encountered in the treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate the clinical and microbiological response of the 405 nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis and in women with healthy gentourine treatment. A clinical trial was conducted involving 40 women, divided into two groups, the first group consisting of women with a confirmed CVV diagnosis and a second group formed by women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both groups underwent clinical evaluation and examination with endocervice collection with gynecologist before and after a session of application of the Blue Light Emitting Diode of 405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary through the questionnaire answered before and after the participants' treatment. It is expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory examination and also improve the signs and results analyzed by the gynecologist and participants.

详细描述

A current treatmente proposal is the use of blue LED of 405 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxigen and it causes cells death with no possibilities of resistance by the fungus.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women betwen 18 and 65 years old, with clinical suspect of vulvovaginal candidiasis and with health vaginal tract

排除标准

  • Women with pacemakers, with diagnosis and / or suspicion of neoplasias, cognitive deficits, neurological and / or psychiatric diseases, pregnant women and women who have used oral antibiotics, fungicides, corticosteroids and vaginal creams in the last 30 days

结局指标

主要结局

Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode

时间窗: 15 days

These exam will be done by the collect of vaginal secretion to analyse types of cells and organisms

Quantification of fungal colony units by the fungus culture in vaginal secretion of women treated by blue light emitting diode

时间窗: 15 days

These exam will be done by the collect of vaginal secretion using Colony Forming Unit CFU in women treated by blue light emitting diode

Value of vaginal pH measurement in women treated by blue light emitting diode

时间窗: 30 minutes

These exam will be done by the collect of vaginal secretion using a ph measuring tape to analyse the hydrogen potential in -log10 \[aH+\] in women treated by blue light emitting diode. It will be used the numeric scale of pH value

Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blue light emitting diode

时间窗: 5 hours

These exam will be done by the collect of vaginal secretion using KOH 10% to analyse clue cells by percentage %

次要结局

未报告次要终点

研究者

发起方
Centro de Atenção ao Assoalho Pélvico
申办方类型
Other
责任方
Sponsor

研究点 (1)

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