A Randomized Open Labeled Parallel Group Study to Compare the Efficacy and Safety of Topical Terbinafine and Miconazole in Patients with Tinea Corporis.
Prince Ekisha Gideon
, Alphienes Stanley Xavier*, Punnagai Kumaravelu and Darling Chellathai DavidDepartment of Pharmacology, Sri Ramachandra Medical College and Research, Institute, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.
Corresponding Author E-mail : alphclinpharm@sriramachandra.edu.in
Abstract: Topical preparations of allylamines and imidazoles are the commonly used medications for the treatment of tinea corporis, having extended efficacy and good safety profile. In our study, we have compared topical terbinafine, an allylamine and topical miconazole, which is an imidazole to assess their efficacy and safety in tinea corporis infection. Hundred patients with tinea corporis infection were equally randomized to receive either terbinafine (1%) or miconazole (2%) for 4 weeks. The reduction in clinical symptoms (pruritus, erythema, vesicle, and desquamation), attaining mycological cure, reduction in composite score, as well as physician global assessment were evaluated from baseline to the end of intervention, and at follow up visit, and compared between the groups. Incidence of adverse drug reactions was also noted for safety analysis. Baseline demographic characteristics of terbinafine and miconazole groups were similar. The study demonstrated statistical significance reduction in clinical symptom scores, attaining Mycological cure, composite score and Physician Global Assessment from baseline to 4th week and follow up week between both groups with a p value <0.05. Compared to terbinafine group, patients received miconazole as intervention had significant successful outcome at the end of treatment (4 weeks) and during the follow-up visit at 5 weeks. Topical miconazole is found to be better and an ideal drug in patients with tinea corporis for the improvement in clinical cure and successful treatment outcome compared to topical terbinafine. Both the drugs are well tolerated drug with the incidence of side effects like itching, irritation, dryness which are comparatively lesser in miconazole group.
Keywords: Antifungal; Clinical Trial; Ring Worm; Tinea Infection Back to TOC