Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vaginal swab culture .
研究概览
简要总结
With the knowledge that VVC is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet A/blue LED with a wavelength of 401 ± 5 nm in patients with a clinical manifestation of candidiasis and its ability to prevent recurrence.
详细描述
Vulvovaginal candidiasis (VVC) is an infection of the vulva and vagina caused by the abnormal growth of several Candida species. This pathology is one of the most common diagnoses in gynecological practice and the second most common genital infection. Studies have shown that 15 to 25% of adult women present with fungal colonization despite being asymptomatic and that 75% of them will develop the disease at some point in their lives.
The treatment of VVC involves the use of antifungal agents, either orally or topically, which resolves 80 to 90% of the cases. However, the use of these agents can lead to the development of adverse reactions such as dysuria, pruritus, and gastrointestinal disorders.
Accordingly, a hypothesis arises that the blue/violet light- emitting diode (LED) may be an alternative treatment for women with VVC because of its antimicrobial effect that has been proven by several studies. Moreover, it is considered a safe, non-invasive, painless, and non-toxic technique for use in several types of tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject selection will be according to the following criteria:
- •Age will range between 18- 50 years.
- •All patients will be confirmed by culture and examination of fresh vaginal samples, to have VVC.
- •All patients who will be enrolled to the study will have their informed consent.
排除标准
- •The participants will be excluded if they meet one of the following criteria:
- •Individuals on any other antifungal drugs.
- •Individuals with cardiopulmonary conditions.
- •Individuals undergoing another radiation therapy.
- •Sensory impairment
研究组 & 干预措施
Group A
This group includes 30 patients will receive routine medical treatment with antifungal, azole (vaginal route).
100 ml ( one Suppository ) at bedtime for three nights in a row
干预措施: Azole Antifungal (Drug)
Group B
This group includes 30 patients. The vulva and vagina will be exposed to 401 ± 5 nm ultraviolet A/ blue LED irradiation in a single session, divided into two applications.
干预措施: Blue Light Emitting Diode Therapy (Device)
结局指标
主要结局
Vaginal swab culture .
时间窗: 2 months
It will be taken before and after the treatment and after one month for assessment of recurrence, by using a potassium hydroxide (KOH) test and fresh cytology with saline solution will be used to analyze the composition of the vaginal discharge under optical microscope
次要结局
- Litmus Paper(2 months)
研究者
Radwa Mohamed Reda Shalaby
Physiotherapist
Cairo University