Patients With Vulvovaginal Candidiasis

NCT ID: NCT03024502

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2020-06-30

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.

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EPP-AF Gel 1%

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

Group Type: EXPERIMENTAL

EPP-AF Gel 1%

Intervention Type: DRUG

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

Clotrimazole cream

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

Group Type: EXPERIMENTAL

Clotrimazole

Intervention Type: DRUG

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

EPP-AF Gel 2%

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

Group Type: EXPERIMENTAL

EPP-AF Gel 2%

Intervention Type: DRUG

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

Interventions

EPP-AF Gel 1%

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

Intervention Type: DRUG

EPP-AF Gel 2%

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

Intervention Type: DRUG

Clotrimazole

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

Intervention Type: DRUG

Other Intervention Names

Drug 1; Drug 2; Active Comparator

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Silvana Maria Quintana

clinical professor and principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

silvana m quintana, phd

Role: PRINCIPAL_INVESTIGATOR

Sao Paulo University

Locations

Clinical Hospital of Sao Paulo University

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

silvana ma quintana, phd

Role: CONTACT

quintana@fmrp.usp.br

5516981459112

anderson silva, phd

Role: CONTACT

asssilva@fmrp.usp.br

551636021000

Facility Contacts

Larissa B Bastos, MSc

Role: primary

larissabbastos4@gmail.com

+55017988034386

Other Identifiers

2013/50496-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

03.12.0056.00

Identifier Type: -

Identifier Source: org_study_id