Patients With Vulvovaginal Candidiasis (EPP-AFG-VVC)

University of Sao Paulo

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: EPP-AF Gel 2%; Drug: Clotrimazole; Drug: EPP-AF Gel 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT03024502

2013/50496-2 (Other Grant/Funding Number)

03.12.0056.00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

EPP-AF Gel 1%

Experimental group

Description:

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

Treatment:

Drug: EPP-AF Gel 1%

Clotrimazole cream

Experimental group

Description:

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

Treatment:

Drug: Clotrimazole

EPP-AF Gel 2%

Experimental group

Description:

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

Treatment:

Drug: EPP-AF Gel 2%