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

NCT04292704 | Unknown

• 1 other identifier: SAHoWMU-CR2020-07-101
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• The difference of vaginal cleanliness between the healthy volunteers and 200 RVVC patients

  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.

  before the intensive therapy

• The difference of the pH value of vagina between the healthy volunteers and 200 RVVC patients

  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.

  before the intensive therapy

• The difference of vaginal microbiological conditions between the healthy volunteers and 200 RVVC patients

  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.

  before the intensive therapy

• The difference of vaginal flora structure between the healthy volunteers and 200 RVVC patients

  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).

  before the intensive therapy

• The changes of vaginal cleanliness between control group and experimental group in different period

  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.

  up to 25 months

• The changes of the pH value of vagina between control group and experimental group in different period

  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.

  up to 25 months

• The changes of the vaginal microbiological conditions between control group and experimental group in different period.

  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.

  up to 25 months

• The changes of vaginal flora structure between control group and experimental group in different period.

  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).

  up to 25 months

• Cure rate

  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).

  up to 25 months

• Recurrence rate of VVC

  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).

  up to 25 months

Study Arms (2)

Laser group

EXPERIMENTAL

Fractional CO2 laser therapy in consolidation treatment once a month for 3 months and treatment was prohibited during menstrual period.

Radiation: the fractional CO2 laser

Clotrimazole group

OTHER

Clotrimazole tablets 500mg PV biw q3d in consolidation treatment once a month for 6 months and treatment was prohibited during the menstrual period.

Drug: Clotrimazole

Interventions

the fractional CO2 laser RADIATION

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

Laser group

Clotrimazole DRUG

Clotrimazole vaginal tablets

Clotrimazole group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• those with autoimmune or immunodeficiency diseases;
• those who received antibiotics or antifungal therapy (including systemic and topical);
• and special drugs and foods within 1 month;
• women during lactation and pregnancy;
• patients with liver insufficiency, neutropenia, adrenocortical dysfunction and diabetes;
• those who are mentally abnormal and can not cooperate normally;
• those who are allergic to clotrimazole vaginal tablets or other imidazole drugs.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Shanghai Pudong Decoding Life Institutes: collaborator

Study Sites (1)

Department of Gynecology of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Clotrimazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ledan Wang, Doctor

CONTACT

+8613858850907; ledanwang331@163.com

Yiqin Hu, Master

CONTACT

+8615158662656; huyiqin1996@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 3, 2020
• Study Start: December 13, 2019
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

CN (1)