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Patients With Vulvovaginal Candidiasis (EPP-AFG-VVC)

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ClinicalTrials.gov Identifier: NCT03024502
Recruitment Status : Not yet recruiting
First Posted : January 18, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Silvana Maria Quintana, University of Sao Paulo

Brief Summary:
The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies with both propolis gels will be performed in comparison with clotrimazole cream in patients presenting vulvovaginal candidiasis.

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: EPP-AF Gel 1% Drug: EPP-AF Gel 2% Drug: Clotrimazole Phase 1 Phase 2

Detailed Description:
Vaginal candidiasis is the second infection of the genital tract after bacterial vaginosis. Up to 75% of women will have at least one episode in their lives, but the clinical manifestations can be very variable. Around 10 to 20% will be asymptomatic and 5 to 10% will have the recurrent candidiasis that means 4 or more episodes in a year. The predominant symptoms are pruritus in 89% and burning during urination and sexual intercourse in 66%. The therapeutic regimen for acute fungal infections by C. albicans should consider the intensity of the clinical symptoms, recurrence, patient preference for the route of administration and consequent adherence to treatment, presence of pregnancy and the possibility of side effects. In general, the schemes include anti-fungal substances of the azoles type. Intravaginal administration of drugs requires the development of formulations suited to the area and adherence to the treatment can be increased if mucoadhesive formulations are obtained which avoid discomfort and provide adequate release of the active compounds. In this sense, the present project had the objective of developing a mucoadhesive gel containing Propolis Standardized (EPP-AF®) for the treatment of vaginal candidiasis, especially since preclinical efficacy and safety data demonstrated the clinical potential of the product. So the present proposal aims at the clinical study evaluate the efficacy of two formulations with 1 and 2% of propolis in comparison with clotrimazole cream treatment (patients affected by Candidiasis) and also evaluate the safety of both propolis gels in healthy volunteers. The efficacy protocol of the test product in patients with vaginal candidiasis will be performed in an open-label, randomized, three-arm, clinical trial with active clotrimazole-based control. Patients will be recruited (T0) and evaluated at 10 and 30 days after initiation of treatment, and the primary outcome will be the clinical cure rate.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis
Study Start Date : January 2017
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: EPP-AF Gel 1%
Group of patients that will be treated with EPP-AF mucoadhesive gel 1%, during 7 day, 1x/day.
Drug: EPP-AF Gel 1%
Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
Other Name: Drug 1

Experimental: Clotrimazole cream
Group of patients that will be treated with clotrimazole cream, during 7 day, 1x/day.
Drug: Clotrimazole
Administration intravaginal of clotrimazol, 1x/day, 7 days
Other Name: Active Comparator

Experimental: EPP-AF Gel 2%
Group of patients that will be treated with EPP-AF mucoadhesive gel 2%, during 7 day, 1x/day.
Drug: EPP-AF Gel 2%
Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
Other Name: Drug 2




Primary Outcome Measures :
  1. clinical cure [ Time Frame: 10 days ]

    Participants will be evaluated on the tenth day after insertion in the study (on the third day after the termination of the vaginal cream). The clinical cure will be evaluated by means of a questionnaire and specular examination. The possibilities will be:

    1. Candidacy Resolution
    2. No resolution of candidiasis

    The questionnaire will be:

    Pruritus: yes or no Burning: yes or no Dysuria: yes or no Edema of the genital area: yes or no Running: yes or no

    The specular examination will evaluate:

    Presence of hyperemia: yes or no Edema of the genital area: yes or no Presence of cracks: yes or no Pathological vaginal contents: yes or no The positive response to any of the questions or signs / symptoms will be considered as clinical failure



Secondary Outcome Measures :
  1. microbiology cure [ Time Frame: 10 days ]

    Participants will be evaluated on the tenth day after insertion in the study (on the third day after the termination of the vaginal cream). The patient's clinical complaint will be evaluated and the specular examination will be performed. In this evaluation will be collected the following exams:

    Vaginal pH measurement:

    Normal 3.5 to 4.5 Abnormal> 4.5

    Bacterioscopy with KOH10%:

    Normal: absence of pseudohifas or other pathogenic elements Abnormal: presence of pseudohifas

    Culture for candida albicans:

    Normal: Negative Abnormal: positive

    PCR for candida:

    Normal negative Abnormal: positive

    The possibilities will be:

    1. Candidacy Resolution
    2. No resolution of candidiasis It will be considered microbiological cure when all laboratory tests are considered normal



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Have performed the clinical and laboratory diagnosis of vulvovaginitis by Candida

Exclusion Criteria:

  • cPatients with recurrent candidiasis;
  • History of hepatic, renal, hematological, cardiovascular diseases and with decompensated diabetes mellitus (glycemia above 200) and obesity with BMI above 35);
  • Diagnosis of vulvovaginitis by another agent;
  • Make use of chronic antimicrobials (informed by the patient)
  • Be pregnant
  • Allergy to some component of medications given

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): NCT03024502


Contacts
Contact: silvana ma quintana, phd 5516981459112 quintana@fmrp.usp.br
Contact: anderson silva, phd 551636021000 asssilva@fmrp.usp.br

Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: silvana m quintana, phd Sao Paulo University

Responsible Party: Silvana Maria Quintana, clinical professor and principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03024502     History of Changes
Other Study ID Numbers: 03.12.0056.00
2013/50496-2 ( Other Grant/Funding Number: FAPESP )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Silvana Maria Quintana, University of Sao Paulo:
vulvovaginal candidiasis
EPPAF mucoadhesive gel
clotrimazol

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases