Vulvovaginal CandidiasisPhase 1/2EPP-AFG-VVCNCT03024502
Patients With Vulvovaginal Candidiasis
A Phase 1/2 study testing EPP-AF Gel 1%, EPP-AF Gel 2% and Clotrimazole in people with Vulvovaginal Candidiasis, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- EPP-AF Gel 1%, EPP-AF Gel 2% and Clotrimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2018to Jun 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Have performed the clinical and laboratory diagnosis of vulvovaginitis by Candida
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Hospital of Sao Paulo University
Ribeirão Preto, São Paulo, 14049-900
Larissa B Bastos, MSc, +55017988034386, larissabbastos4@gmail.com
About this study
Official title: Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis
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.
Read the 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
- Being tested
- EPP-AF Gel 1%, EPP-AF Gel 2%, Clotrimazole
- Keywords
- vulvovaginal candidiasis, EPPAF mucoadhesive gel, clotrimazol
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPP-AF Gel 1%Drug
Also called Drug 1
Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
EPP-AF Gel 2%Drug
Also called Drug 2
Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
ClotrimazoleDrug
Also called Active Comparator
Administration intravaginal of clotrimazol, 1x/day, 7 days
| Study group | Role | What they receive |
|---|---|---|
| EPP-AF Gel 1% | Experimental | Group of patients that will be treated with EPP-AF mucoadhesive gel 1%, during 7 day, 1x/day. Receives: Drug: EPP-AF Gel 1% |
| Clotrimazole cream | Experimental | Group of patients that will be treated with clotrimazole cream, during 7 day, 1x/day. Receives: Drug: Clotrimazole |
| EPP-AF Gel 2% | Experimental | Group of patients that will be treated with EPP-AF mucoadhesive gel 2%, during 7 day, 1x/day. Receives: Drug: EPP-AF Gel 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical cure
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
Measured: 10 days
Secondary outcomes (1)
microbiology cure
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start30 Jan 2018
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvana Maria Quintana, University of Sao Paulo
- Investigators
- silvana m quintana, phd, Principal investigator, Sao Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024502
- Sponsor's protocol ID
- 03.12.0056.00
- Other IDs
- 2013/50496-2
- Acronym
- EPP-AFG-VVC
- Status last verified
- Oct 2018
- First submitted
- 12 Jan 2017
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT03024502
- Acronym / sponsor ID
- EPP-AFG-VVC / 03.12.0056.00
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- vulvovaginal candidiasis, EPPAF mucoadhesive gel, clotrimazol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPP-AF Gel 1% | Experimental | Drug: EPP-AF Gel 1%Group of patients that will be treated with EPP-AF mucoadhesive gel 1%, during 7 day, 1x/day. |
| Clotrimazole cream | Experimental | Drug: ClotrimazoleGroup of patients that will be treated with clotrimazole cream, during 7 day, 1x/day. |
| EPP-AF Gel 2% | Experimental | Drug: EPP-AF Gel 2%Group of patients that will be treated with EPP-AF mucoadhesive gel 2%, during 7 day, 1x/day. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Have performed the clinical and laboratory diagnosis of vulvovaginitis by Candida
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPP-AF Gel 1%Also: Drug 1Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days | Drug | EPP-AF Gel 1% |
| EPP-AF Gel 2%Also: Drug 2Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days | Drug | EPP-AF Gel 2% |
| ClotrimazoleAlso: Active ComparatorAdministration intravaginal of clotrimazol, 1x/day, 7 days | Drug | Clotrimazole cream |
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: 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
1 secondary outcome
microbiology cure
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
silvana m quintana, phd principal investigator
Sao Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EPP-AF Gel 1%, EPP-AF Gel 2% and Clotrimazole in people with Vulvovaginal Candidiasis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact silvana ma quintana, phd (5516981459112, quintana@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical cure (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.