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

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ClinicalTrials.gov Identifier: NCT03500107
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
University of Messina
Salvatore Giovanni Vitale M.D.
Information provided by (Responsible Party):
Centro de Atenção ao Assoalho Pélvico

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 responde 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.

Condition or disease Intervention/treatment Phase
Vaginosis, Bacterial Device: Blue Light Emitting Diode (LED) 401 +/- 5nm Not Applicable

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 oxigen and it causes cells death with no possibilities of resistance by the bacterium.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
Estimated Study Start Date : May 2, 2018
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

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 ginecological 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 Name: Questionnaire of anamnesis




Primary Outcome Measures :
  1. Description of types of cells done by oncology and microflora citology in women treated by blue LED of 401 +/- 5nm [ Time Frame: 15 days ]
    This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms

  2. Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blu LED of 401 +/- 5nm [ Time Frame: 10 minutes ]
    This exam will be done by the collect of vaginal secretion using KOH 10%

  3. Value of vaginal pH measurement in women treated by blue LED [ Time Frame: 2 minutes ]
    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

  4. Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED [ Time Frame: 15 days ]
    This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women, betwen 18 - 45 years old, with diagnosis of bacterial vaginosis.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500107


Contacts
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Contact: Patricia Lordelo +55 71 3330 1640 pvslordelo@hotmail.com
Contact: Patricia Lordelo +55 71 3276 8260 pvslordelo@hotmail.com

Sponsors and Collaborators
Centro de Atenção ao Assoalho Pélvico
University of Messina
Salvatore Giovanni Vitale M.D.
Investigators
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Study Director: Patricia Lordelo Centro de Atenção ao Assoalho Pélvico

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Responsible Party: Centro de Atenção ao Assoalho Pélvico
ClinicalTrials.gov Identifier: NCT03500107     History of Changes
Other Study ID Numbers: Centro CAAP
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centro de Atenção ao Assoalho Pélvico:
Blue Light Emitting Diode
Women

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis