NCT03024502

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

January 12, 2017

Last Update Submit

October 17, 2018

Conditions

Vulvovaginal Candidiasis

Keywords

vulvovaginal candidiasisEPPAF mucoadhesive gelclotrimazol

Outcome Measures

Primary Outcomes (1)

  • clinical cure

    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 Outcomes (1)

  • microbiology cure

    10 days

Study Arms (3)

EPP-AF Gel 1%

EXPERIMENTAL

Group of patients that will be treated with EPP-AF mucoadhesive gel 1%, during 7 day, 1x/day.

Drug: EPP-AF Gel 1%

Clotrimazole cream

EXPERIMENTAL

Group of patients that will be treated with clotrimazole cream, during 7 day, 1x/day.

Drug: Clotrimazole

EPP-AF Gel 2%

EXPERIMENTAL

Group of patients that will be treated with EPP-AF mucoadhesive gel 2%, during 7 day, 1x/day.

Drug: EPP-AF Gel 2%

Interventions

EPP-AF Gel 1%DRUG

Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days

Also known as: Drug 1
EPP-AF Gel 1%
EPP-AF Gel 2%DRUG

Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days

Also known as: Drug 2
EPP-AF Gel 2%
ClotrimazoleDRUG

Administration intravaginal of clotrimazol, 1x/day, 7 days

Also known as: Active Comparator
Clotrimazole cream

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of Sao Paulo University

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Clotrimazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • silvana m quintana, phd

    Sao Paulo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

silvana ma quintana, phd

CONTACT

5516981459112quintana@fmrp.usp.br

anderson silva, phd

CONTACT

551636021000asssilva@fmrp.usp.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor and principal investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 18, 2017

Study Start

January 30, 2018

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)