Safety and tolerability of cinnamaldehyde in orabase for oral candidiasis treatment: phase I clinical trial

• Published in: Clinical oral investigations Vol. 26; no. 7; pp. 4825 - 4833
• Main Authors: da Nóbrega Alves, Danielle, Melo, Ana Karoline Vieira, Alves, Adriano Francisco, de Araújo, Maria Rejane Cruz, da Silva Araújo, Rubens, de Castro, Ricardo Dias
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.07.2022; Springer Nature B.V
• Subjects: Antimicrobial agents; Burning; Candida; Candidiasis; Cellular biology; Cinnamaldehyde; Clinical trials; Cytology; Dentistry; Fungal infections; Inflammation; Medicine; Mucosa; Ointments; Original Article; Safety; Sensation; Antimicrobial products; Antifungal; Biological products; Oral candidiasis
• ISSN: 1436-3771; 1432-6981; 1436-3771
• DOI: 10.1007/s00784-022-04450-9

Objective To advance studies on the effect of a new pharmaceutical formulation for the treatment of oral fungal infections, we evaluated the safety and tolerability of orabase ointment containing cinnamaldehyde for use on the oral mucosa. Material and methods A clinical trial (phase I) was carried out on 35 individuals with healthy oral mucosa divided into three groups: ointments at 200 µg/mL, n  = 12; 300 µg/mL, n  = 11; and 400 µg/mL, n  = 12. Product safety was assessed using three parameters: (a) clinical evolution as recorded by trained examiners; (b) evolution of the inflammatory process as registered by an exfoliative cytology exam and analyzed by trained pathologists; (c) mucosal swab to count Candida spp. colony-forming units (CFU). These parameters were analyzed both beforehand and at 15 days of treatment. Results The three ointment concentrations evaluated did not trigger inflammatory processes. The mycological analyses revealed a reduction of at least 99% in the number of Candida spp. CFU. In the exfoliative cytology analyses, the cells were found to be healthy. Participants reported a pleasant taste, yet 17% reported a slight burning sensation when applying the product. Conclusions The ointment is safe and tolerable for use on healthy oral mucosa. Trial registration Registration number: RBR-7zwzs3. Clinical relevance The ointment proved to be safe and tolerable for use on oral mucosa, encouraging studies to evaluate its clinical efficacy in patients with oral candidiasis, and contributing to a new therapeutic proposal for the treatment of fungal infections caused by Candida spp.