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

Centro de Atenção ao Assoalho Pélvico

Status: Enrolling

Conditions: Candidiasis, Vulvovaginal

Treatments: Other: Questionnaire of anamnesis; Device: Blue LED 405 nm

Study type: Interventional

Funder types: Other

Identifiers

NCT03075046

CentroAAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

blue LED 405 nm in vulvovaginal candidiasis

Experimental group

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

Treatment:

Device: Blue LED 405 nm

Other: Questionnaire of anamnesis

blue LED 405 nm in healthy women

Experimental group

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

Treatment:

Device: Blue LED 405 nm

Other: Questionnaire of anamnesis

Sociodemographic data of women with vulvovaginal candidiasis

No Intervention group

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