Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial

Study Overview
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Brief Summary
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Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an important health issue due to the high incidence and difficulties encountered in the treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate the clinical and microbiological response of the 405 nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis and in women with healthy gentourine treatment. A clinical trial was conducted involving 40 women, divided into two groups, the first group consisting of women with a confirmed CVV diagnosis and a second group formed by women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both groups underwent clinical evaluation and examination with endocervice collection with gynecologist before and after a session of application of the Blue Light Emitting Diode of 405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary through the questionnaire answered before and after the participants' treatment. It is expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory examination and also improve the signs and results analyzed by the gynecologist and participants.

Detailed Description
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A current treatmente proposal is the use of blue LED of 405 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxigen and it causes cells death with no possibilities of resistance by the fungus.

Official Title
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Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial

Conditions
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Candidiasis, Vulvovaginal

Intervention / Treatment
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* Device: Blue LED 405 nm
* Other: Questionnaire of anamnesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women betwen 18 and 65 years old, with clinical suspect of vulvovaginal candidiasis and with health vaginal tract Exclusion Criteria: Women with pacemakers, with diagnosis and / or suspicion of neoplasias, cognitive deficits, neurological and / or psychiatric diseases, pregnant women and women who have used oral antibiotics, fungicides, corticosteroids and vaginal creams in the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blue LED 405 nm in vulvovaginal candidiasis<br>It will be applied the a 405 nm blue LED in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session. This part of the study will see if there is fungicidal effect of the blue led 405 nm | Device: Blue LED 405 nm<br>* It will be applied a 405 nm blue Tonderm LED with a power of 1.66 W / m2, in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session.<br>Other: Questionnaire of anamnesis<br>* The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist<br>|
| Experimental: blue LED 405 nm in healthy women<br>It will be applied the a 405 nm blue LED in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session.This part of the study will see the security and the effects of the blue led 405 nm in healthy vaginal microflora | Device: Blue LED 405 nm<br>* It will be applied a 405 nm blue Tonderm LED with a power of 1.66 W / m2, in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session.<br>Other: Questionnaire of anamnesis<br>* The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist<br>|
| No Intervention: Sociodemographic data of women with vulvovaginal candidiasis<br>The women will answer some questions of the anamnesis as: Age, weight, height, form of intimate hygiene, and others to evaluate possible correlations of these data with the presence of vulvovaginal candidiasis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode | These exam will be done by the collect of vaginal secretion to analyse types of cells and organisms | 15 days | 
| Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blue light emitting diode | These exam will be done by the collect of vaginal secretion using KOH 10% to analyse clue cells by percentage % | 5 hours | 
| Value of vaginal pH measurement in women treated by blue light emitting diode | These exam will be done by the collect of vaginal secretion using a ph measuring tape to analyse the hydrogen potential in -log10 [aH+] in women treated by blue light emitting diode. It will be used the numeric scale of pH value | 30 minutes | 
| Quantification of fungal colony units by the fungus culture in vaginal secretion of women treated by blue light emitting diode | These exam will be done by the collect of vaginal secretion using Colony Forming Unit CFU in women treated by blue light emitting diode | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blue Light Emitting Diode, Women