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

NCT03075046 | Unknown DMC

• 1 other identifier: CentroAAP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Candidiasis, Vulvovaginal

Keywords

Blue Light Emitting Diode; Women

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

blue LED 405 nm in vulvovaginal candidiasis

EXPERIMENTAL

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

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

blue LED 405 nm in healthy women

EXPERIMENTAL

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

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

Sociodemographic data of women with vulvovaginal candidiasis

NO INTERVENTION

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

Interventions

Blue LED 405 nm DEVICE

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.

blue LED 405 nm in healthy women; blue LED 405 nm in vulvovaginal candidiasis

Questionnaire of anamnesis OTHER

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

blue LED 405 nm in healthy women; blue LED 405 nm in vulvovaginal candidiasis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women betwen 18 and 65 years old, with clinical suspect of vulvovaginal candidiasis and with health vaginal tract

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead
• Vitale SG M.D.: collaborator
• University of Messina: collaborator

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 36395084 DERIVED

• 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.

  PMID: 30406341 DERIVED

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Central Study Contacts

Patrícia Lordêlo, post doc

CONTACT

5571 988592400; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 9, 2017
• Study Start: April 20, 2017
• Primary Completion: February 20, 2018
• Study Completion: December 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)