Vulvovaginal Candidiasis, GenitalNCT04292704
A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis
A study testing the fractional CO2 laser and Clotrimazole in people with Vulvovaginal Candidiasis, Genital and Laser Therapy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis, Genital, Laser Therapy
- What is being tested?
- the fractional CO2 laser and Clotrimazole
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2019to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- those who did not meet the above inclusion criteria;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gynecology of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yiqin Hu, Master, +8615158662656, huyiqin1996@163.com
About this study
Official title: The Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) ：a Study Protocol for a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
- 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
2.2.1 Control group: Clotrimazole tablets 500mg PV biw q3d in consolidation therapy, with or without injector, the tablets are placed deep in the vagina once a month for 6 months. Treatment is prohibited during the menstrual period.
2.2.2 Experimental group: The fractional CO2 laser therapeutic machine will be used with wavelength 10.6 μ m, output power 40 w, action time 2000 μ s, lattice spacing 700 ~ 1000 μ m, gradually retreated from the vagina to the vaginal orifice according to the 5mm distance, and irradiated the vagina at 360 °once a month for 3 consecutive months as a course of treatment. Treatment is prohibited during menstrual period.
- Sample collection and detection
3.1 Collection: Vaginal secretion samples will be collected from patients with RVVC before and after intensive therapy, at the end of consolidation therapy, and at 3, 6 and 12 months after consolidation therapy. The vaginal secretions samples of 5 volunteers will be collected when signing the informed consent. After emptying the urine, the participants take the lithotomy position in the gynecological examination bed, fully exposed the vulva and perineum. The gynecologists expose the cervix with a disposable vaginal dilator, collect the vaginal posterior fornix secretion with two disposable vaginal aseptic cotton swabs. Then the investigators send one sample to the Second Affiliated Hospital of WMU for vaginal discharge laboratory examination, put another sample into the 1.5ml cryopreservation tube and seal it in a liquid nitrogen tank at -80 ℃. These samples will be submitted to Shanghai Pudong Decoding Life Institutes for vaginal flora structure detection within 3 months.
3.2 Vaginal discharge laboratory examination: The Second Affiliated Hospital of WMU will take up the laboratory examination, including vaginal cleanliness, pH value of vagina, vaginal microbiological conditions. The use of a microscope to examine vaginal secretions wet smears and staining smears to observe their cleanliness and the presence of special bacteria and cells to confirm vaginal cleanliness and vaginal microbiological conditions. Vaginal pH value will be determined by the precise pH test paper method.
- Follow-up visit: The investigatorswill take follow-up visit with RVVC patients at 3,6 and 12 months after consolidation therapy, and vaginal secretions samples will be collected for fungal culture to compare the vaginal microecological environment, evaluate clinical cure rate and recurrences of infection. Besides, the investigators will carry out targeted treatment for recurrent patients and again collect vaginal secretions sample to detect and analyze the species abundance and structure of vaginal flora.
5.Data analysis: ①By comparing the vaginal microecological environment (vaginal cleanliness, pH value of vagina, vaginal microbiological conditions and vaginal flora structure) between the normal control group (n=5) and 200 RVVC patients before the intensive therapy, the investigators will verify the vaginal microecological environment of RVVC patients has changed, and find out the difference between healthy women and RVVC patients. ②By comparing the vaginal microecological environment 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 investigators will find out the change of vaginal microecological environment in all treatment and development stages of RVVC, verify whether the fractional CO2 laser could restore the normal pH value of vagina, improve vaginal microecological environment, restore the proportion of vaginal flora or not. ③By comparing the cure rate and recurrence rate of VVC between control group (n=100) and experimental group (n=100) at 3, 6 and 12 months after consolidation therapy, the investigators can draw which treatment effect is better between fractional CO2 laser consolidation therapy and traditional antifungal consolidation therapy for RVVC.
- Conditions
- Vulvovaginal Candidiasis, Genital, Laser Therapy
- Being tested
- the fractional CO2 laser, Clotrimazole
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the fractional CO2 laserRadiation
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
ClotrimazoleDrug
Clotrimazole vaginal tablets
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | Fractional CO2 laser therapy in consolidation treatment once a month for 3 months and treatment was prohibited during menstrual period. Receives: 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. Receives: Drug: Clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start13 Dec 2019
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal Candidiasis, GenitalStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong Decoding Life Institutes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292704
- Sponsor's protocol ID
- SAHoWMU-CR2020-07-101
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) ：a Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04292704
- Acronym / sponsor ID
- SAHoWMU-CR2020-07-101
- Conditions
- Vulvovaginal Candidiasis, Genital, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Pudong Decoding Life Institutes
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
2.2.1 Control group: Clotrimazole tablets 500mg PV biw q3d in consolidation therapy, with or without injector, the tablets are placed deep in the vagina once a month for 6 months. Treatment is prohibited during the menstrual period.
2.2.2 Experimental group: The fractional CO2 laser therapeutic machine will be used with wavelength 10.6 μ m, output power 40 w, action time 2000 μ s, lattice spacing 700 ~ 1000 μ m, gradually retreated from the vagina to the vaginal orifice according to the 5mm distance, and irradiated the vagina at 360 °once a month for 3 consecutive months as a course of treatment. Treatment is prohibited during menstrual period.
- Sample collection and detection
3.1 Collection: Vaginal secretion samples will be collected from patients with RVVC before and after intensive therapy, at the end of consolidation therapy, and at 3, 6 and 12 months after consolidation therapy. The vaginal secretions samples of 5 volunteers will be collected when signing the informed consent. After emptying the urine, the participants take the lithotomy position in the gynecological examination bed, fully exposed the vulva and perineum. The gynecologists expose the cervix with a disposable vaginal dilator, collect the vaginal posterior fornix secretion with two disposable vaginal aseptic cotton swabs. Then the investigators send one sample to the Second Affiliated Hospital of WMU for vaginal discharge laboratory examination, put another sample into the 1.5ml cryopreservation tube and seal it in a liquid nitrogen tank at -80 ℃. These samples will be submitted to Shanghai Pudong Decoding Life Institutes for vaginal flora structure detection within 3 months.
3.2 Vaginal discharge laboratory examination: The Second Affiliated Hospital of WMU will take up the laboratory examination, including vaginal cleanliness, pH value of vagina, vaginal microbiological conditions. The use of a microscope to examine vaginal secretions wet smears and staining smears to observe their cleanliness and the presence of special bacteria and cells to confirm vaginal cleanliness and vaginal microbiological conditions. Vaginal pH value will be determined by the precise pH test paper method.
- Follow-up visit: The investigatorswill take follow-up visit with RVVC patients at 3,6 and 12 months after consolidation therapy, and vaginal secretions samples will be collected for fungal culture to compare the vaginal microecological environment, evaluate clinical cure rate and recurrences of infection. Besides, the investigators will carry out targeted treatment for recurrent patients and again collect vaginal secretions sample to detect and analyze the species abundance and structure of vaginal flora.
5.Data analysis: ①By comparing the vaginal microecological environment (vaginal cleanliness, pH value of vagina, vaginal microbiological conditions and vaginal flora structure) between the normal control group (n=5) and 200 RVVC patients before the intensive therapy, the investigators will verify the vaginal microecological environment of RVVC patients has changed, and find out the difference between healthy women and RVVC patients. ②By comparing the vaginal microecological environment 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 investigators will find out the change of vaginal microecological environment in all treatment and development stages of RVVC, verify whether the fractional CO2 laser could restore the normal pH value of vagina, improve vaginal microecological environment, restore the proportion of vaginal flora or not. ③By comparing the cure rate and recurrence rate of VVC between control group (n=100) and experimental group (n=100) at 3, 6 and 12 months after consolidation therapy, the investigators can draw which treatment effect is better between fractional CO2 laser consolidation therapy and traditional antifungal consolidation therapy for RVVC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser group | Experimental | Radiation: the fractional CO2 laserFractional CO2 laser therapy in consolidation treatment once a month for 3 months and treatment was prohibited during menstrual period. |
| Clotrimazole group | Other | Drug: ClotrimazoleClotrimazole tablets 500mg PV biw q3d in consolidation treatment once a month for 6 months and treatment was prohibited during the menstrual period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- those who did not meet the above inclusion criteria;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the fractional CO2 laserThe 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 | Radiation | Laser group |
| ClotrimazoleClotrimazole vaginal tablets | Drug | Clotrimazole group |
Primary outcome
The difference of vaginal cleanliness between the healthy volunteers and 200 RVVC patients
Time frame: 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 difference of the pH value of vagina between the healthy volunteers and 200 RVVC patients
Time frame: 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
Time frame: 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.
The difference of vaginal flora structure between the healthy volunteers and 200 RVVC patients
Time frame: 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 cleanliness between control group and experimental group in different period
Time frame: 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
Time frame: 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 changes of the vaginal microbiological conditions between control group and experimental group in different period.
Time frame: 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 changes of vaginal flora structure between control group and experimental group in different period.
Time frame: 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).
Cure rate
Time frame: 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).
Recurrence rate of VVC
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the fractional CO2 laser and Clotrimazole in people with Vulvovaginal Candidiasis, Genital and Laser Therapy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ledan Wang, Doctor (+8613858850907, ledanwang331@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of vaginal cleanliness between the healthy volunteers and 200 RVVC patients (time frame: before the intensive therapy). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.