The Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) ：a Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- The difference of vaginal cleanliness between the healthy volunteers and 200 RVVC patients
研究概览
简要总结
Background: Recurrent vulvovaginal candidiasis (RVVC) is a common obstinate vulvovaginal inflammation in gynecology. At present, the pathogenesis of RVVC is not clear. In recent years, it is emphasized that the changes of vaginal microecological environment play an important role in the occurrence and development of RVVC. The treatment of RVVC can be divided into intensive treatment and consolidation treatment. Currently, local antifungal treatment is the main treatment regimen. While it is difficult and had an insufficient effect on prevention from recurrence of clinical signs and the improvement of vaginal mycological status in long term. Besides, there is no mature consolidation treatment regimen at home and abroad. Through the current application of the fractional CO2 laser in the treatment of atrophic vaginitis, it is confirmed that local irradiation of the fractional CO2 laser on vulva and vagina can regenerate and repair mucosal tissue, enhance the function of vaginal epithelial cells, gradually restore the normal pH value of vagina, improve vaginal microecological environment, restore the proportion of vaginal flora and reduce the recurrence rate of RVVC. This trial aims to explore the efficacy of two consolidation therapy schemes: the fractional CO2 laser and traditional antifungal drugs.
Methods/Design: The ongoing study will include 200 RVVC patients who voluntarily joined the study and signed the informed consent form the Second Affiliated Hospital of WMU during December 2019 to March 2022. After patients were cured by transvaginal local drug intensive therapy, participants will be randomly divided into control group (n = 100) and experimental group (n = 100). The control group continue to receive a monthly course of vaginal local drug consolidation therapy for 6 months, while the experimental group will be given monthly local vaginal CO2 laser consolidation therapy for 3 months. The vaginal secretions samples of RVVC patients will be collected before intensive therapy, after intensive therapy and at the end of consolidation therapy, and the species abundance and structure of vaginal flora were detected and analyzed. In the same period, 5 healthy women of childbearing age were recruited as the normal control group and the volunteers do not take any treatment. The vaginal secretions samples of 5 volunteers will be collected when signing the informed consent to detect and analyze the species abundance and structure of vaginal flora.
The patients with RVVC will be followed up for 3, 6 and 12 months after the treatment and vaginal secretions samples will be collected for vaginal flora structure detection to compare the vaginal microecological environment. For recurrent patients, the investigators will carry out targeted treatment, and again collect vaginal secretions sample to detect and analyze the species abundance and structure of vaginal flora.
Objectives: The aim of this study is to compare the effects of fractional CO2 laser consolidation therapy and traditional antifungal consolidation therapy for RVVC, and assess the role of fractional CO2 laser in changes of vaginal microecological environment and recurrence rate of VVC after consolidation treatment.
详细描述
- Study design and general procedures
200 RVVC patients will be selected according to the above eligibility criteria form the Second Affiliated Hospital of WMU during December 2019 to March 2022. Women will be informed about the study protocol, procedures, investigational product and potential risks of treatment. After 200 RVVC patients were cured (mycological cured) by traditional intensive antifungal drug treatment, they will be randomly divided into control group (n=100) and experimental group (n=100). The control group continued to receive one course of Clotrimazole vaginal tablets for consolidation therapy once a month for 6 months, and the experimental group will be given the fractional CO2 laser therapy once a month for 3 months. In the same period, 5 healthy women of childbearing age will be recruited as the normal control group, and the normal control group do not receive any treatments.
2.Treatment
2.1 Intensive treatment: Clotrimazole tablets 500mg PV biw Q3d, with or without injector, the tablets are placed deep in the vagina for 2 weeks.
2.2 Consolidation treatment
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Laser group
Fractional CO2 laser therapy in consolidation treatment once a month for 3 months and treatment was prohibited during menstrual period.
干预措施: the fractional CO2 laser (Radiation)
Clotrimazole group
Clotrimazole tablets 500mg PV biw q3d in consolidation treatment once a month for 6 months and treatment was prohibited during the menstrual period.
干预措施: Clotrimazole (Drug)
结局指标
主要结局
The difference of vaginal cleanliness between the healthy volunteers and 200 RVVC patients
时间窗: before the intensive therapy
Compare the vaginal cleanliness between the normal control group (n=5) and 200 RVVC patients. The criteria of vaginal cleanliness were as follow: Grade I was mainly gram-positive rods (indicative of Lactobacillus spp.), a large number of vaginal epithelial cells, and no other bacteria observed with WBC 0\~5/HP under microscopy. Grade II was some Lactobacillus spp. and vaginal epithelial cells, some pus cells, and other bacteria observed under microscopy with WBC 10\~15/HP. Grade III was a small amount of Lactobacillus spp. and vaginal epithelial cells, a large number of pus cells and other bacteria observed under microscopy with WBC 15\~30/HP. Grade IV was no Lactobacillus spp., but pus cells and other bacteria observed under microscopy with WBC more than 30/HP.
The changes of the vaginal microbiological conditions between control group and experimental group in different period.
时间窗: up to 25 months
Compare the vaginal microbiological conditions between control group (n=100) and experimental group (n=100) in different period (before and after intensive therapy, at the end of consolidation therapy, and at 3, 6 and 12 months after consolidation therapy). Fungi, trichomonas, Neisseria gonorrhoeae and other items. If there is, then marked on the results "+" (positive), no is "-" (negative). Normal: none.
The difference of the pH value of vagina between the healthy volunteers and 200 RVVC patients
时间窗: before the intensive therapy
Compare the pH value of vagina between the normal control group (n=5) and 200 RVVC patients. Vaginal pH value will be determined by the precise pH test paper method. The paper should include a range of pH from 4.0 to above 5.0. The normal pH is 4.5 or less.
The difference of vaginal microbiological conditions between the healthy volunteers and 200 RVVC patients
时间窗: before the intensive therapy
Compare the vaginal microbiological conditions between the normal control group (n=5) and 200 RVVC patients. Fungi, trichomonas, Neisseria gonorrhoeae and other items. If there is, then marked on the results "+" (positive), no is "-" (negative). Normal: none.
Cure rate
时间窗: up to 25 months
The criteria of cure: no clinical symptoms; vaginal cleanliness in gradeⅠ \~ Ⅱ; no Candida spores or hyphae were found in vaginal secretions samples detection at 3, 6 and 12 months after consolidation therapy. The rate of cured number in control group and experimental group (precent).
The changes of vaginal cleanliness between control group and experimental group in different period
时间窗: up to 25 months
Compare the vaginal cleanliness between control group (n=100) and experimental group (n=100) in different period (before and after intensive therapy, at the end of consolidation therapy, and at 3, 6 and 12 months after consolidation therapy). The criteria of vaginal cleanliness were as follow: Grade I was mainly gram-positive rods (indicative of Lactobacillus spp.), a large number of vaginal epithelial cells, and no other bacteria observed with WBC 0\~5/HP under microscopy. Grade II was some Lactobacillus spp. and vaginal epithelial cells, some pus cells, and other bacteria observed under microscopy with WBC 10\~15/HP. Grade III was a small amount of Lactobacillus spp. and vaginal epithelial cells, a large number of pus cells and other bacteria observed under microscopy with WBC 15\~30/HP. Grade IV was no Lactobacillus spp., but pus cells and other bacteria observed under microscopy with WBC more than 30/HP.
The changes of the pH value of vagina between control group and experimental group in different period
时间窗: up to 25 months
Compare the pH value of vagina between control group (n=100) and experimental group (n=100) in different period (before and after intensive therapy, at the end of consolidation therapy, and at 3, 6 and 12 months after consolidation therapy). Vaginal pH value will be determined by the precise pH test paper method. The paper should include a range of pH from 4.0 to above 5.0. The normal pH is 4.5 or less.
The difference of vaginal flora structure between the healthy volunteers and 200 RVVC patients
时间窗: before the intensive therapy
Compare the difference of vaginal flora structure between the normal control group (n=5) and 200 RVVC patients. The structure will be showed by the percentage of specific species (precent).
The changes of vaginal flora structure between control group and experimental group in different period.
时间窗: up to 25 months
Compare the vaginal flora structure between control group (n=100) and experimental group (n=100) in different period (before and after intensive therapy, at the end of consolidation therapy, and at 3, 6 and 12 months after consolidation therapy). The structure will be showed by the percentage of specific species (precent).
Recurrence rate of VVC
时间窗: up to 25 months
The criteria of recurrence: cured at the end of consolidation therapy, during the follow-up visit at 3,6 and 12 months after consolidation therapy, recurrence of VVC. The rate of recurrenced number in control group and experimental group (precent).
次要结局
未报告次要终点