Clinical trial NCT03075046: Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
Official title: Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Candidiasis, Vulvovaginal
Keywords: Blue Light Emitting Diode
Women
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
Collaborators: name: Vitale SG M.D.
name: University of Messina
First posted: 2017-03-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode
timeFrame: 15 days
measure: Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blue light emitting diode
timeFrame: 5 hours
measure: Value of vaginal pH measurement in women treated by blue light emitting diode
timeFrame: 30 minutes
measure: Quantification of fungal colony units by the fungus culture in vaginal secretion of women treated by blue light emitting diode
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao Assoalho Pelvico
state: Ba
Study officials:
References:
citation: 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.
citation: Pavie 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.