Patients With Vulvovaginal Candidiasis (EPP-AFG-VVC)

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

Study Description

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 Design

• 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
• Actual Study Start Date: January 30, 2018
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: June 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: silvana ma quintana, phd; 5516981459112; quintana@fmrp.usp.br

Contact: anderson silva, phd; 551636021000; asssilva@fmrp.usp.br

Locations

Brazil

Clinical Hospital of Sao Paulo University; Recruiting

Ribeirao Preto, Sao Paulo, Brazil, 14049-900

Contact: Larissa B Bastos, MSc +55017988034386 larissabbastos4@gmail.com

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 ( Other Grant/Funding Number: FAPESP )
• First Posted: January 18, 2017
• Last Update Posted: October 19, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: 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