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

Candidiasis, Vulvovaginal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075046
• Other study ID #: CentroAAP
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: Patrícia Lordêlo, post doc
• Phone: 5571 988592400
• Email: pvslordelo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal

Intervention

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

Locations

Country	Name	City	State
Brazil	Centro de Atenção ao Assoalho Pelvico	Salvador	Ba

Sponsors (3)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico	University of Messina, Vitale SG M.D.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode	These exam will be done by the collect of vaginal secretion to analyse types of cells and organisms	15 days
Primary	Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blue light emitting diode	These exam will be done by the collect of vaginal secretion using KOH 10% to analyse clue cells by percentage %	5 hours
Primary	Value of vaginal pH measurement in women treated by blue light emitting diode	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	30 minutes
Primary	Quantification of fungal colony units by the fungus culture in vaginal secretion of women treated by blue light emitting diode	These exam will be done by the collect of vaginal secretion using Colony Forming Unit CFU in women treated by blue light emitting diode	15 days