Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial

Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.

Study Overview

• Status: Recruiting
• Conditions: Vaginosis, Bacterial
• Intervention / Treatment: Device: Blue Light Emitting Diode (LED) 401 +/- 5nm

Detailed Description

A current treatment proposal is the use of blue LED of 401 +/- 5 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxygen and it causes cells death with no possibilities of resistance by the bacterium.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Lordelo; Phone Number: +55 71 3330 1640; Email: pvslordelo@hotmail.com
• Study Contact Backup: Name: Patricia Lordelo; Phone Number: +55 71 3276 8260; Email: pvslordelo@hotmail.com

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40290000
      • Recruiting
      • Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública
      • Contact: Patrícia Lordelo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• women with 18 to 65 years old and with diagnosis of bacterial vaginosis

Exclusion Criteria:

• women with injury seen by Pap smear, or in use of pacemaker, with diagnosis or suspicion of neoplasias, with heart diseases, pregnant or with diagnosis of epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blue LED 401 +/- 5 nm; The Blue LED 401 +/- 5 nm will be applied in the participant, in a closed room by a physiotherapist for 1 hour. The apparatus will be supported on a tripod, statically, externally, 5 cm away from the vulva abd vaginal region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol consists of only one session. This part of the study will see if there is bactericidal effect of the blue LED.

Device: Blue Light Emitting Diode (LED) 401 +/- 5nm; The participant will be naked, in a gynecological stretcher and lithotomy position, and the apparatus of the LED will be positioned in front of the vulva and vaginal region, 5 cm away, it will be statically, externally, and supported on a tripod. The protocol will consist of only one session.; Other Names: Questionnaire of anamnesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of vaginal pH measurement in women treated by blue LED	This exam will be done by the collect of vaginal secretion using a pH measuring tape to analyse the hydrogen potential in -log 10 [pH+] in women treated by blue LED. It will be used the numeric scale of pH value	2 minutes
Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED	This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED	15 days
Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm	This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms	15 days
Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm	This exam will be done by the collect of vaginal secretion using KOH 10%	10 minutes

Collaborators and Investigators

• Sponsor: Centro de Atenção ao Assoalho Pélvico
• Collaborators: University of Messina; Salvatore Giovanni Vitale M.D.
• Investigators: Study Director: Patricia Lordelo, Centro de Atenção ao assoalho pélvico

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Women; Blue Light Emitting Diode
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: Centro CAAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No