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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03075046
Enrollment
40
Registered
2017-03-09
Start date
2017-04-20
Completion date
2023-12-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis, Vulvovaginal

Keywords

Blue Light Emitting Diode, Women

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.

Interventions

DEVICEBlue 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.

OTHERQuestionnaire of anamnesis

The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist

Sponsors

Vitale SG M.D.
CollaboratorUNKNOWN
University of Messina
CollaboratorOTHER
Centro de Atenção ao Assoalho Pélvico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode15 daysThese 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 diode5 hoursThese 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 diode30 minutesThese 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 diode15 daysThese exam will be done by the collect of vaginal secretion using Colony Forming Unit CFU in women treated by blue light emitting diode

Countries

Brazil

Contacts

Primary ContactPatrícia Lordêlo, post doc
pvslordelo@hotmail.com5571 988592400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026