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Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis (NCT03024502)

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.
  • Drug: EPP-AF Gel 1%
    Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
    • Drug 1
  • Drug: EPP-AF Gel 2%
    Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
    • Drug 2
  • Drug: Clotrimazole
    Administration intravaginal of clotrimazol, 1x/day, 7 days
    • Active Comparator
Ages eligible for Study
18 Years to 49 Years
Genders eligible for Study
Female
Accepts Healthy 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
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.
Status:
not yet recruiting
Type:
Interventional
Phase:
Ⅰ, Ⅱ
Start:
31 December, 2016
Updated:
28 January, 2017
Participants:
90
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