Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic
Primary Purpose
Candidiasis, Oral, Stomatitis, Denture
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Propolis
Miconazole
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Oral focused on measuring propolis, therapeutic, miconazole, denture stomatitis
Eligibility Criteria
Inclusion Criteria:
- Elderly patients with denture stomatitis
Exclusion Criteria:
- Recent use of anti fungals or antibiotics(2 months or less), dementia
Sites / Locations
- Unievangelica Anapolis
- Unidade de Pesquisa Clinica HCRP-USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propolis
Miconazole
Arm Description
Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days
Miconazole 20mg/g oral gel,3 times a day, for 14 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assessment of gel acceptability
Application of hedonic scale on day 7
Assessment of adverse events
Questioning about rise of adverse events on days 7 and 14
Anti fungal activity
Colony forming unit count (CFU/mL) on days 1 and 14
Full Information
NCT ID
NCT02818803
First Posted
June 21, 2016
Last Updated
June 27, 2016
Sponsor
University of Sao Paulo
Collaborators
Financiadora de Estudos e Projetos
1. Study Identification
Unique Protocol Identification Number
NCT02818803
Brief Title
Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic
Official Title
Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Financiadora de Estudos e Projetos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, Stomatitis, Denture
Keywords
propolis, therapeutic, miconazole, denture stomatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propolis
Arm Type
Experimental
Arm Description
Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days
Arm Title
Miconazole
Arm Type
Active Comparator
Arm Description
Miconazole 20mg/g oral gel,3 times a day, for 14 days
Intervention Type
Other
Intervention Name(s)
Propolis
Intervention Type
Drug
Intervention Name(s)
Miconazole
Other Intervention Name(s)
Daktarin oral gel
Primary Outcome Measure Information:
Title
Change from Newton Score at 14 days
Description
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.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Assessment of gel acceptability
Description
Application of hedonic scale on day 7
Time Frame
Day 7
Title
Assessment of adverse events
Description
Questioning about rise of adverse events on days 7 and 14
Time Frame
Day 7 and 14
Title
Anti fungal activity
Description
Colony forming unit count (CFU/mL) on days 1 and 14
Time Frame
Day 1 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elderly patients with denture stomatitis
Exclusion Criteria:
Recent use of anti fungals or antibiotics(2 months or less), dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica N Lia, PhD
Organizational Affiliation
Faculdade de Medicina de Ribeirão Preto/USP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gisela M Pina, DDS
Organizational Affiliation
Unievangelica Anapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unievangelica Anapolis
City
Anapolis
State/Province
Goias
ZIP/Postal Code
75083515
Country
Brazil
Facility Name
Unidade de Pesquisa Clinica HCRP-USP
City
Ribeirao Preto
State/Province
São Paulo
ZIP/Postal Code
14048900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26916845
Citation
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.
Results Reference
result
PubMed Identifier
18696746
Citation
Santos 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 Reference
result
PubMed Identifier
16161031
Citation
Santos 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.
Results Reference
result
Learn more about this trial
Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic
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