An interventional study of Blue LED 405 nm and Questionnaire of anamnesis in Candidiasis, Vulvovaginal, sponsored by Centro de Atenção ao Assoalho Pélvico. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Centro de Atenção ao Assoalho Pélvico · Not applicable, Interventional, and Treatment
Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an important health issue due to the high incidence and difficulties encountered in the treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate the clinical and microbiological response of the 405 nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis and in women with healthy gentourine treatment. A clinical trial was conducted involving 40 women, divided into two groups, the first group consisting of women with a confirmed CVV diagnosis and a second group formed by women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both groups underwent clinical evaluation and examination with endocervice collection with gynecologist before and after a session of application of the Blue Light Emitting Diode of 405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary through the questionnaire answered before and after the participants' treatment. It is expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory examination and also improve the signs and results analyzed by the gynecologist and participants.
A current treatmente proposal is the use of blue LED of 405 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 fungus.
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's planned enrollment of 40 is below the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →Centro de Atenção ao Assoalho Pélvico is the lead sponsor of 17 studies on the registry; 13 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It will be applied the a 405 nm blue LED in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session. This part of the study will see if there is fungicidal effect of the blue led 405 nm
Device: Blue LED 405 nm · Other: Questionnaire of anamnesis
It will be applied the a 405 nm blue LED in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session.This part of the study will see the security and the effects of the blue led 405 nm in healthy vaginal microflora
Device: Blue LED 405 nm · Other: Questionnaire of anamnesis
The women will answer some questions of the anamnesis as: Age, weight, height, form of intimate hygiene, and others to evaluate possible correlations of these data with the presence of vulvovaginal candidiasis
It will be applied a 405 nm blue Tonderm LED with a power of 1.66 W / m2, in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session.
The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist
Description of types of cells done by oncology and microflora cytology in women treated by blue light emitting diode
These exam will be done by the collect of vaginal secretion to analyse types of cells and organisms
Time frame: 15 days
Amount of clue cells quantified by fresh citology in vaginal secretion of women treated by blue light emitting diode
These exam will be done by the collect of vaginal secretion using KOH 10% to analyse clue cells by percentage %
Time frame: 5 hours
Value of vaginal pH measurement in women treated by blue light emitting diode
These exam will be done by the collect of vaginal secretion using a ph measuring tape to analyse the hydrogen potential in -log10 \[aH+\] in women treated by blue light emitting diode. It will be used the numeric scale of pH value
Time frame: 30 minutes
Quantification of fungal colony units by the fungus culture in vaginal secretion of women treated by blue light emitting diode
These exam will be done by the collect of vaginal secretion using Colony Forming Unit CFU in women treated by blue light emitting diode
Time frame: 15 days
Plan to share: No
Ran from Apr 2017 to primary completion in Feb 2018, 10 months.
Of 20 interventional studies with no phase under Candidiasis, Vulvovaginal, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 10 months is close to that.
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Centro de Atenção ao Assoalho Pélvico