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

Primary Purpose

Vaginosis, Bacterial

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Blue Light Emitting Diode (LED) 401 +/- 5nm
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginosis, Bacterial focused on measuring Blue Light Emitting Diode, Women

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde PúblicaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blue LED 401 +/- 5 nm

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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%
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
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

Secondary Outcome Measures

Full Information

First Posted
April 9, 2018
Last Updated
June 21, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
Collaborators
University of Messina, Salvatore Giovanni Vitale M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT03500107
Brief Title
Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
Official Title
Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Atenção ao Assoalho Pélvico
Collaborators
University of Messina, Salvatore Giovanni Vitale M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Bacterial
Keywords
Blue Light Emitting Diode, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blue LED 401 +/- 5 nm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Blue Light Emitting Diode (LED) 401 +/- 5nm
Other Intervention Name(s)
Questionnaire of anamnesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm
Description
This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms
Time Frame
15 days
Title
Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm
Description
This exam will be done by the collect of vaginal secretion using KOH 10%
Time Frame
10 minutes
Title
Value of vaginal pH measurement in women treated by blue LED
Description
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
Time Frame
2 minutes
Title
Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED
Description
This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED
Time Frame
15 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Lordelo
Phone
+55 71 3330 1640
Email
pvslordelo@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Lordelo
Phone
+55 71 3276 8260
Email
pvslordelo@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Lordelo
Organizational Affiliation
Centro de Atenção ao Assoalho Pélvico
Official's Role
Study Director
Facility Information:
Facility Name
Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40290000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrícia Lordelo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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