Patients With Vulvovaginal Candidiasis (EPP-AFG-VVC)

October 17, 2018 updated by: Silvana Maria Quintana, University of Sao Paulo

Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14049-900
        • Recruiting
        • Clinical Hospital of Sao Paulo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Drug 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: silvana m quintana, phd, Sao Paulo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03.12.0056.00
  • 2013/50496-2 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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