Clinical Trial: Patients With Vulvovaginal Candidiasis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: 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 Summary: 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.
Sponsor: University of Sao Paulo
Current Primary Outcome: 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:
- Candidacy Resolution
- 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: 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
Current Secondary Outcome: 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:
- Candidacy Resolution
- No resolution of candidiasis It will be considered microbiological cure when all laboratory tests are considered normal
Original Secondary Outcome: 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
Information By: University of Sao Paulo
Dates:
Date Received: January 12, 2017
Date Started: January 2017
Date Completion: December 2017
Last Updated: January 29, 2017
Last Verified: January 2017
