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

NCT03075046 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-22

No results posted yet for this study

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.

Conditions

  • Candidiasis, Vulvovaginal

Interventions

DEVICE

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.

OTHER

Questionnaire of anamnesis

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

Sponsors & Collaborators

  • Vitale SG M.D.

    collaborator UNKNOWN
  • University of Messina

    collaborator OTHER
  • Centro de Atenção ao Assoalho Pélvico

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2018-02-20
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075046 on ClinicalTrials.gov