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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Centro de Atenção ao Assoalho Pélvico

Current 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centro de Atenção ao Assoalho Pélvico

Dates:
Date Received: February 22, 2017
Date Started: April 2017
Date Completion: February 20, 2019
Last Updated: March 8, 2017
Last Verified: March 2017