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

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.

Conditions

• Vulvovaginal Candidiasis, Genital
• Laser Therapy

Interventions

RADIATION

the fractional CO2 laser

The fractional CO2 laser therapy mechine: the wavelength is 10.6 μ m, the output power is 40 w, the action time is 2000 μ s and the lattice spacing is 700 \~ 1000 μ m

DRUG

Clotrimazole

Clotrimazole vaginal tablets

Sponsors & Collaborators

• Shanghai Pudong Decoding Life Institutes

  collaborator UNKNOWN

• Second Affiliated Hospital of Wenzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-12-13

Primary Completion

2022-03-31

Completion

2022-05-31

Countries

• China

Study Locations