Candidiasis, OralPhase 3NCT02818803
Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic
A Phase 3 study testing Propolis and Miconazole in people with Candidiasis, Oral and Stomatitis, Denture, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Candidiasis, Oral, Stomatitis, Denture
- What is being tested?
- Propolis and Miconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2016to Jun 2016
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients with denture stomatitis
Who cannot join
- Recent use of anti fungals or antibiotics(2 months or less), dementia
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Unievangelica Anapolis
Anápolis, Goiás, 75083515
Unidade de Pesquisa Clinica HCRP-USP
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People
The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.
- Conditions
- Candidiasis, Oral, Stomatitis, Denture
- Being tested
- Propolis, Miconazole
- Keywords
- propolis, therapeutic, miconazole, denture stomatitis
- Medical subject headings
- Candidiasis, Oral, Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisOther
MiconazoleDrug
Also called Daktarin oral gel
| Study group | Role | What they receive |
|---|---|---|
| Propolis | Experimental | Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days Receives: Other: Propolis |
| Miconazole | Active comparator | Miconazole 20mg/g oral gel,3 times a day, for 14 days Receives: Drug: Miconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Newton Score at 14 days
Clinical assessment of buccal lesions localized at hard palate. The score utilized to measure the intensity of lesions will be Newton classification (I - punctate in the palate; II - extensive smooth reddened appearance; III -extensive reddening with hyperplastic growth) and the outcome will be the reduction of Newton's score comparing day 1 with day 14.
Measured: Day 14
Secondary outcomes (3)
Assessment of gel acceptability
Application of hedonic scale on day 7
Measured: Day 7
Assessment of adverse events
Questioning about rise of adverse events on days 7 and 14
Measured: Day 7 and 14
Anti fungal activity
Colony forming unit count (CFU/mL) on days 1 and 14
Measured: Day 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, OralStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Principal investigator, Erica Negrini Lia, University of Sao Paulo
- Investigators
- Erica N Lia, PhD, Principal investigator, Faculdade de Medicina de Ribeirão Preto/USPGisela M Pina, DDS, Principal investigator, Unievangelica Anapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818803
- Sponsor's protocol ID
- 1057529
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Freires IA, Queiroz VCPP, Furletti VF, Ikegaki M, de Alencar SM, Duarte MCT, Rosalen PL. Chemical composition and antifungal potential of Brazilian propolis against Candida spp. J Mycol Med. 2016 Jun;26(2):122-132. doi: 10.1016/j.mycmed.2016.01.003. Epub 2016 Feb 23.
PubMed 26916845Santos VR, Gomes RT, de Mesquita RA, de Moura MD, Franca EC, de Aguiar EG, Naves MD, Abreu JA, Abreu SR. Efficacy of Brazilian propolis gel for the management of denture stomatitis: a pilot study. Phytother Res. 2008 Nov;22(11):1544-7. doi: 10.1002/ptr.2541.
PubMed 18696746Santos VR, Pimenta FJ, Aguiar MC, do Carmo MA, Naves MD, Mesquita RA. Oral candidiasis treatment with Brazilian ethanol propolis extract. Phytother Res. 2005 Jul;19(7):652-4. doi: 10.1002/ptr.1715.
PubMed 16161031
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People
- ClinicalTrials.gov ID
- NCT02818803
- Acronym / sponsor ID
- 1057529
- Conditions
- Candidiasis, Oral, Stomatitis, Denture
- Keywords
- propolis, therapeutic, miconazole, denture stomatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jun 2016 (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 purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Other: PropolisStandardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days |
| Miconazole | Active comparator | Drug: MiconazoleMiconazole 20mg/g oral gel,3 times a day, for 14 days |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly patients with denture stomatitis
Key exclusion criteria (1 listed)
- Recent use of anti fungals or antibiotics(2 months or less), dementia
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 |
|---|---|---|
| Propolis | Other | Propolis |
| MiconazoleAlso: Daktarin oral gel | Drug | Miconazole |
Primary outcome
Change from Newton Score at 14 days
Time frame: Day 14
Clinical assessment of buccal lesions localized at hard palate. The score utilized to measure the intensity of lesions will be Newton classification (I - punctate in the palate; II - extensive smooth reddened appearance; III -extensive reddening with hyperplastic growth) and the outcome will be the reduction of Newton's score comparing day 1 with day 14.
3 secondary outcomes
Assessment of gel acceptability
Time frame: Day 7
Assessment of adverse events
Time frame: Day 7 and 14
Anti fungal activity
Time frame: Day 1 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Results publication: PubMed 26916845Freires IA, Queiroz VCPP, Furletti VF, Ikegaki M, de Alencar SM, Duarte MCT, Rosalen PL. Chemical composition and antifungal potential of Brazilian propolis against Candida spp. J Mycol Med. 2016 Jun;26(2):122-132. doi: 10.1016/j.mycmed.2016.01.003. Epub 2016 Feb 23.
- Results publication: PubMed 18696746Santos VR, Gomes RT, de Mesquita RA, de Moura MD, Franca EC, de Aguiar EG, Naves MD, Abreu JA, Abreu SR. Efficacy of Brazilian propolis gel for the management of denture stomatitis: a pilot study. Phytother Res. 2008 Nov;22(11):1544-7. doi: 10.1002/ptr.2541.
- Results publication: PubMed 16161031Santos VR, Pimenta FJ, Aguiar MC, do Carmo MA, Naves MD, Mesquita RA. Oral candidiasis treatment with Brazilian ethanol propolis extract. Phytother Res. 2005 Jul;19(7):652-4. doi: 10.1002/ptr.1715.
- Individual participant dataSharing planned: Undecided
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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.
Erica N Lia, PhD principal investigator
Faculdade de Medicina de Ribeirão Preto/USP
Gisela M Pina, DDS principal investigator
Unievangelica Anapolis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propolis and Miconazole in people with Candidiasis, Oral and Stomatitis, Denture, run by University of Sao Paulo at 2 sites 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 1 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: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Newton Score at 14 days (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818803, which also lists 3 linked publications.
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 30 Jun 2016; AzTrials last refreshed its copy on 31 Oct 2026.