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Trial record 21 of 27 for:    Clotrimazole AND Fungal Infections

Patients With Vulvovaginal Candidiasis (EPP-AFG-VVC)

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ClinicalTrials.gov Identifier: NCT03024502
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Silvana Maria Quintana, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE January 12, 2017
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date October 19, 2018
Actual Study Start Date  ICMJE January 30, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
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 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
Change History Complete list of historical versions of study NCT03024502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
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 It will be considered microbiological cure when all laboratory tests are considered normal
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patients With Vulvovaginal Candidiasis
Official Title  ICMJE Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Candidiasis
Intervention  ICMJE
  • Drug: EPP-AF Gel 1%
    Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
    Other Name: Drug 1
  • Drug: EPP-AF Gel 2%
    Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
    Other Name: Drug 2
  • Drug: Clotrimazole
    Administration intravaginal of clotrimazol, 1x/day, 7 days
    Other Name: Active Comparator
Study Arms  ICMJE
  • Experimental: EPP-AF Gel 1%
    Group of patients that will be treated with EPP-AF mucoadhesive gel 1%, during 7 day, 1x/day.
    Intervention: Drug: EPP-AF Gel 1%
  • Experimental: Clotrimazole cream
    Group of patients that will be treated with clotrimazole cream, during 7 day, 1x/day.
    Intervention: Drug: Clotrimazole
  • Experimental: EPP-AF Gel 2%
    Group of patients that will be treated with EPP-AF mucoadhesive gel 2%, during 7 day, 1x/day.
    Intervention: Drug: EPP-AF Gel 2%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: silvana ma quintana, phd 5516981459112 quintana@fmrp.usp.br
Contact: anderson silva, phd 551636021000 asssilva@fmrp.usp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03024502
Other Study ID Numbers  ICMJE 03.12.0056.00
2013/50496-2 ( Other Grant/Funding Number: FAPESP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Silvana Maria Quintana, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: silvana m quintana, phd Sao Paulo University
PRS Account University of Sao Paulo
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP