- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075046
Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
June 21, 2023 updated by: Centro de Atenção ao Assoalho Pélvico
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patrícia Lordêlo, post doc
- Phone Number: 5571 988592400
- Email: pvslordelo@hotmail.com
Study Locations
-
-
Ba
-
Salvador, Ba, Brazil, 40.290-000
- Recruiting
- Centro de Atenção ao assoalho pélvico
-
Contact:
- Patricia V Lordelo, Phd
- Phone Number: +5571988592400
- Email: pvslordelo@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: blue LED 405 nm in vulvovaginal candidiasis
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 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.
The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist
|
Experimental: blue LED 405 nm in healthy women
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
|
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.
The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist
|
No Intervention: Sociodemographic data of women with vulvovaginal candidiasis
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?
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
Time Frame: 15 days
|
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
Time Frame: 5 hours
|
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
Time Frame: 30 minutes
|
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
Time Frame: 15 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
February 20, 2018
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
February 22, 2017
First Submitted That Met QC Criteria
March 8, 2017
First Posted (Actual)
March 9, 2017
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 21, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Vaginal Diseases
- Vulvar Diseases
- Vaginitis
- Vulvitis
- Vulvovaginitis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Candidiasis
- Candidiasis, Vulvovaginal
Other Study ID Numbers
- CentroAAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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