Clinical trial NCT03500107: 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
Overall status: RECRUITING
Phase: NA
Conditions: Vaginosis, Bacterial
Keywords: Blue Light Emitting Diode
Women
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
Collaborators: name: University of Messina
name: Salvatore Giovanni Vitale M.D.
First posted: 2018-04-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm
timeFrame: 15 days
measure: Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm
timeFrame: 10 minutes
measure: Value of vaginal pH measurement in women treated by blue LED
timeFrame: 2 minutes
measure: Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública
state: Bahia
Study officials:
affiliation: Centro de Atenção ao Assoalho Pélvico
name: Patricia Lordelo
role: STUDY_DIRECTOR
References: