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

Primary Purpose

Candidiasis, Vulvovaginal

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Blue LED 405 nm
Questionnaire of anamnesis
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Vulvovaginal focused on measuring Blue Light Emitting Diode, Women

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centro de Atenção ao Assoalho PelvicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

blue LED 405 nm in vulvovaginal candidiasis

blue LED 405 nm in healthy women

Sociodemographic data of women with vulvovaginal candidiasis

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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 %
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
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

Secondary Outcome Measures

Full Information

First Posted
February 22, 2017
Last Updated
June 21, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
Collaborators
Vitale SG M.D., University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT03075046
Brief Title
Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
Official Title
Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Atenção ao Assoalho Pélvico
Collaborators
Vitale SG M.D., University of Messina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Vulvovaginal
Keywords
Blue Light Emitting Diode, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
blue LED 405 nm in vulvovaginal candidiasis
Arm Type
Experimental
Arm Description
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
Arm Title
blue LED 405 nm in healthy women
Arm Type
Experimental
Arm Description
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
Arm Title
Sociodemographic data of women with vulvovaginal candidiasis
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Blue LED 405 nm
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire of anamnesis
Intervention Description
The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist
Primary Outcome Measure Information:
Title
Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode
Description
These exam will be done by the collect of vaginal secretion to analyse types of cells and organisms
Time Frame
15 days
Title
Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blue light emitting diode
Description
These exam will be done by the collect of vaginal secretion using KOH 10% to analyse clue cells by percentage %
Time Frame
5 hours
Title
Value of vaginal pH measurement in women treated by blue light emitting diode
Description
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
Time Frame
30 minutes
Title
Quantification of fungal colony units by the fungus culture in vaginal secretion of women treated by blue light emitting diode
Description
These exam will be done by the collect of vaginal secretion using Colony Forming Unit CFU in women treated by blue light emitting diode
Time Frame
15 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrícia Lordêlo, post doc
Phone
5571 988592400
Email
pvslordelo@hotmail.com
Facility Information:
Facility Name
Centro de Atenção ao Assoalho Pelvico
City
Salvador
State/Province
Ba
ZIP/Postal Code
40.290-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia V Lordelo, Phd
Phone
+5571988592400
Email
pvslordelo@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36395084
Citation
Pereira E Silva ACM, Brito MB, Robatto M, Pavie MC, Villas Boas AQ, Sousa R, Lordelo P. Blue Light-Emitting Diode Therapy for Chronic Vulvovaginitis Symptoms: A Series of Cases. Photobiomodul Photomed Laser Surg. 2022 Nov;40(11):747-750. doi: 10.1089/photob.2022.0038.
Results Reference
derived
PubMed Identifier
30406341
Citation
Pavie MC, Robatto M, Bastos M, Tozetto S, Boas AV, Vitale SG, Lordelo P. Blue light-emitting diode in healthy vaginal mucosa-a new therapeutic possibility. Lasers Med Sci. 2019 Jul;34(5):921-927. doi: 10.1007/s10103-018-2678-3. Epub 2018 Nov 7.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://aplicacao.saude.gov.br/plataformabrasil/login.jsf

Learn more about this trial

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

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