Efficacy and safety of miconazole muco-adhesive tablet versus itraconazole in oropharyngeal candidiasis: A randomized, multi-centered, double-blind, phase 3 trial

Abstract

Oropharyngeal candidiasis (OPC) is an opportunistic infection treated with anti-fungal agents. Herein, we evaluate the efficacy and safety of miconazole buccal tablets (MBT) and itraconazole capsules in the localized treatment of patients with OPC. In this multi-centered, double-blinded, phase III trial (CTR20130414), both males and non-pregnant females (≥18 years) with OPC were randomized (1:1) to MBT plus placebo (experimental group) or itraconazole capsules plus placebo (control group). The primary endpoint was clinical cure at the end-of-treatment period [visit 4 (V4)] while secondary endpoints were clinical remission rates, partial remission rates, mycological cure, clinical relapse, and adverse events (AEs). All endpoints were statistically analyzed in both full analysis set (FAS) and per-protocol (PP) set. A total of 431 (experimental: 216; control: 215) subjects were included. At V4, in the FAS set, the clinical cure was achieved in 68% and 59% patients in experimental and control groups, respectively with a treatment difference of 9% (95% CI: -1,19; P < 0.001) demonstrating non-inferiority of MBT over itraconazole. At V4, mycological cure rates were 68.2% and 42.0% in the experimental group and control groups (P < 0.001), respectively in FAS. The relapse rates were 5.4% and 6.6%, respectively, in the experimental and control groups. A total of 210 patients experienced AEs during treatment with 47.7% in the experimental group and 49.8% in the control group with no deaths. This study demonstrated that once-daily treatment with MBT was non-inferior to itraconazole with higher mycological cure rates and was tolerable with mild AE in patients with OPC.

The anti-fungal effect of miconazole and miconazole-loaded chitosan nanoparticles gels in diabetic patients with Oral candidiasis-randomized control clinical trial and microbiological analysis

“…The use of Chitosan nanoparticles loaded with antifungal drug is a relatively new drug delivery system, and their long-term efficacy are not yet fully established, far to our knowledge, only one study to our knowledge had assessed the effect of nystatin loaded in chitosan nanoparticles clinically [ 22 ], and due to the superior effect of miconazole over nystatin in the treatment of oral candidiasis regarding efficacy, rapidity of curing, adverse effects, and recurrence rate [ 38 , 43 ] miconazole was used in this study incorporated with chitosan nanoparticles for the treatment of oral candidiasis. This study aimed to evaluate the therapeutic effects of topical application of miconazole-loaded chitosan nanoparticles (CS-MCZ nanoparticles gel) compared to miconazole gel alone (MZ) in the treatment of oral candidiasis in diabetic patients.…”