A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Collaborator: Shanghai Pudong Decoding Life Institutes
• Treatments: Clotrimazole; Miconazole

Criteria

200 RVVC patients will be eligible for the trial if they fulfil the following criterion:

1. women aged 18 to 60;

2. chief complaint: vulvar itching, burning pain, sexual intercourse pain and urine pain, leucorrhea increased, occurring 4 or more times a year;

3. gynecological examination: vulvar erythema, edema, often accompanied by scratches, vaginal mucosa red and swollen, the inside of the labia minor and vaginal mucosa with white lumps, curd or bean curd-like, red and swollen mucous membrane exposed after erasure;

4. laboratory examination: microscopic examination of vaginal secretions to find the spores or hyphae of Candida albicans;

5. sign the informed consent form voluntarily.

5 healthy volunteers as the normal control group will be eligible for the trial if they fulfil the following criterion:

1. women aged 18 to 60;

2. no clinical symptoms;

3. vaginal cleanliness grade Ⅰ ~ Ⅱ;

4. laboratory examination: Candida spores or hyphae were not found in vaginal secretions;

5. menstruation was normal;

6. voluntary informed consent was signed.

Exclusion criteria:

1. those who did not meet the above inclusion criteria;

2. those with autoimmune or immunodeficiency diseases;

3. those who received antibiotics or antifungal therapy (including systemic and topical);

4. and special drugs and foods within 1 month;

5. women during lactation and pregnancy;

6. patients with liver insufficiency, neutropenia, adrenocortical dysfunction and diabetes;

7. those who are mentally abnormal and can not cooperate normally;

8. those who are allergic to clotrimazole vaginal tablets or other imidazole drugs.