Candidiasis, VulvovaginalNCT03075046
Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
A study testing Blue LED 405 nm and Questionnaire of anamnesis in people with Candidiasis, Vulvovaginal, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Blue LED 405 nm and Questionnaire of anamnesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2017to Dec 2023
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women betwen 18 and 65 years old, with clinical suspect of vulvovaginal candidiasis and with health vaginal tract
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, 40.290-000
Patricia V Lordelo, Phd, +5571988592400, pvslordelo@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Blue LED 405 nm, Questionnaire of anamnesis
- Keywords
- Blue Light Emitting Diode, Women
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue LED 405 nmDevice
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.
Questionnaire of anamnesisOther
The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| blue LED 405 nm in vulvovaginal candidiasis | Experimental | 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 Receives: Device: Blue LED 405 nm; Other: Questionnaire of anamnesis |
| blue LED 405 nm in healthy women | Experimental | 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 Receives: Device: Blue LED 405 nm; Other: Questionnaire of anamnesis |
| Sociodemographic data of women with vulvovaginal candidiasis | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 %
Measured: 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
Measured: 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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start20 Apr 2017
- Primary completion20 Feb 2018
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, VulvovaginalStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Collaborators
- Vitale SG M.D., University of Messina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075046
- Sponsor's protocol ID
- CentroAAP
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2017
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36395084Pavie 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.
PubMed 30406341
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
- ClinicalTrials.gov ID
- NCT03075046
- Acronym / sponsor ID
- CentroAAP
- Conditions
- Candidiasis, Vulvovaginal
- Keywords
- Blue Light Emitting Diode, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Collaborators
- Vitale SG M.D., University of Messina
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Mar 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| blue LED 405 nm in vulvovaginal candidiasis | Experimental | Device: Blue LED 405 nm, Other: Questionnaire of anamnesisIt 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 |
| blue LED 405 nm in healthy women | Experimental | Device: Blue LED 405 nm, Other: Questionnaire of anamnesisIt 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 |
| Sociodemographic data of women with vulvovaginal candidiasis | No intervention | –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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women betwen 18 and 65 years old, with clinical suspect of vulvovaginal candidiasis and with health vaginal tract
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Blue LED 405 nmIt 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. | Device | blue LED 405 nm in healthy women, blue LED 405 nm in vulvovaginal candidiasis |
| Questionnaire of anamnesisThe participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist | Other | blue LED 405 nm in healthy women, blue LED 405 nm in vulvovaginal candidiasis |
Primary outcome
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
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 %
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 36395084Pereira 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.
- Derived from this study: PubMed 30406341Pavie 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.
- Individual participant dataSharing planned: No
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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 Blue LED 405 nm and Questionnaire of anamnesis in people with Candidiasis, Vulvovaginal, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
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 1 inclusion and 1 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 22 Jun 2023. 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 Brazil. 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 Patrícia Lordêlo, post doc (5571 988592400, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode (time frame: 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075046, which also lists 2 linked publications.
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 22 Jun 2023.