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

Vaginosis, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03500107
• Other study ID #: Centro CAAP
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Vaginal Diseases
• Vaginosis, Bacterial

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