Status:
UNKNOWN
A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Shanghai Pudong Decoding Life Institutes
Conditions:
Vulvovaginal Candidiasis, Genital
Laser Therapy
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 emphasize...
Detailed Description
1\. 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. W...
Eligibility Criteria
Inclusion
- 200 RVVC patients will be eligible for the trial if they fulfil the following criterion:
- women aged 18 to 60;
- chief complaint: vulvar itching, burning pain, sexual intercourse pain and urine pain, leucorrhea increased, occurring 4 or more times a year;
- 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;
- laboratory examination: microscopic examination of vaginal secretions to find the spores or hyphae of Candida albicans;
- 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:
- women aged 18 to 60;
- no clinical symptoms;
- vaginal cleanliness grade Ⅰ \~ Ⅱ;
- laboratory examination: Candida spores or hyphae were not found in vaginal secretions;
- menstruation was normal;
- voluntary informed consent was signed.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04292704
Start Date
December 13 2019
End Date
May 1 2022
Last Update
March 11 2020
Active Locations (1)
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1
Department of Gynecology of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000