Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic

Candidiasis, Oral Clinical Trial

Official title:

Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818803
• Other study ID #: 1057529
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2016
• Last updated: June 27, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Elderly patients with denture stomatitis

Exclusion Criteria:

• Recent use of anti fungals or antibiotics(2 months or less), dementia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• Stomatitis
• Stomatitis, Denture

Intervention

Other:
• Propolis

Drug:
• Miconazole

Locations

Country	Name	City	State
Brazil	Unievangelica Anapolis	Anapolis	Goias
Brazil	Unidade de Pesquisa Clinica HCRP-USP	Ribeirao Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Financiadora de Estudos e Projetos

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Freires IA, Queiroz VC, Furletti VF, Ikegaki M, de Alencar SM, Duarte MC, Rosalen PL. Chemical composition and antifungal potential of Brazilian propolis against Candida spp. J Mycol Med. 2016 Jun;26(2):122-32. doi: 10.1016/j.mycmed.2016.01.003. Epub 2016 — View Citation

Santos VR, Gomes RT, de Mesquita RA, de Moura MD, França 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.25 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 14	No
Secondary	Assessment of gel acceptability	Application of hedonic scale on day 7	Day 7	No
Secondary	Assessment of adverse events	Questioning about rise of adverse events on days 7 and 14	Day 7 and 14	Yes
Secondary	Anti fungal activity	Colony forming unit count (CFU/mL) on days 1 and 14	Day 1 and 14	No