Comparison of clotrimazole troche and a novel clotrimazole varnish

Objective: To evaluate and compare a novel sustained release clotrimazole varnish (SRCV) to an existing oral clotrimazole therapy in the treatment of oral candidiasis. Methods: Denture wearers clinically diagnosed with oral candidiasis were divided randomly to study group treated by SRCV (50 mg of clotrimazole) which was applied once a day and control group treated by equivalent 5 troches of 10 mg clotrimazole/day. Both groups were treated for 14 days. Microbiological samples were obtained by imprint culture of the oral mucosa (palate and buccal surfaces). Erythema was evaluated in a 3 degree scale and patients' compliance was recorded - all in days 0,7and 14. Results: Seven patients (mean age 73 years) participated in this study. At the end of the study a considerable improvement in the level of oral average erythema was recorded in the study and control groups (0.6 to 0 and 1 to 0.25 respectively). Significant reduction in the average levels of fungi in the study group (by 66.4%) compared to the control group (30.3%) was observed. No fungi were recorded following one week administration of SRV compared to decrease by 61% (mean) in control group from the mucosa. Patient compliance to the SRCV treatment was much higher than to the conventional treatment. One participant of control group had not received full treatment. Conclusion: Improved compliance, prolonged release and clinical efficacy of the clotrimazole are great advantages of the new anti fungal SRV for patients suffering from oral candidiasis. Further clinical study is needed to be conducted.

Acknowledgment: This study was partially supported by the P&G Innovation Award