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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03500107
Other study ID # Centro CAAP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2018
Est. completion date December 20, 2025

Study information

Verified date March 2024
Source Centro de Atenção ao Assoalho Pélvico
Contact Patricia Lordelo
Phone +55 71 3330 1640
Email pvslordelo@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 20, 2025
Est. primary completion date December 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública Salvador Bahia

Sponsors (3)

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

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 LED of 401 +/- 5nm This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms 15 days
Primary 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
Primary 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
Primary 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
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