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Patients With Vulvovaginal Candidiasis (EPP-AFG-VVC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Silvana Maria Quintana, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT03024502
First received: January 12, 2017
Last updated: January 13, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Vulvovaginal Candidiasis
Drug: EPP-AF Gel 1%
Drug: EPP-AF Gel 2%
Drug: Clotrimazole
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • clinical cure [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

    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 through a questionnaire and specular examination:

    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:
  • microbiology cure [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

    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 It will be considered microbiological cure when all laboratory tests are considered normal



Estimated Enrollment: 90
Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: January 12, 2017
Last Updated: January 13, 2017
Health Authority: Brazil: Ethical Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on January 18, 2017