CLINICAL EFFICACY AND SAFETY OF TRIPLE COMBINATION CREAM CONTAINING MOMETASONE FUROATE, MICONAZOLE NITRATE, AND GENTAMICIN AS A TOPICAL TREATMENT FOR MIXED SKIN INFECTIONS WITH FUNGI AND BACTERIA

*Mai Hussein El-Samahy, Eman Moustafa Kamel Ahmed Sanad, Basma Mourad Mohamed Aly, and Samia Mohamed Essmat Mahmoud

ABSTRACT

Background: Fixed dose combinations of corticosteroids, antibacterials and antifungals are known to alleviate inflammatory skin conditions. This study aimed to evaluate the safety and clinical efficacy of the topical application of a triple combination of mometasone furoate, miconazole nitrate and gentamicin in a cream base for mixed skin infections. Materials and Methods: Patients with mixed skin infections were prescribed Momenta™ cream, at the sole discretion of their physicians, for 7 to 14 days. Results: A total of 416 patients were enrolled from 4 sites in this study; of which, 375 were eligible for primary efficacy analysis. The median (IQR) total score of all signs and symptoms was significantly decreased from 11 (7) at baseline to 1 (3) at the end of treatment duration, with a median reduction of 10 points (p < 0.0001). At the end of treatment, 89.9% of patients achieved ≥ 50% relative improvement in total score of all signs and symptoms. A total of 4 patients experienced 7 adverse events during the study period. Pruritus was reported by 4 patients while burning sensation was reported by 3 patients. None of the events was serious. Conclusion: The triple combination cream of mometasone furoate, miconazole nitrate and gentamicin have acceptable efficacy and safety profile in the treatment of mixed skin infections with bacteria and fungi.

Keywords: skin conditions, antibacterials, antifungals, corticosteroids, mixed infections