A real-world observational study to evaluate the safety & effectiveness of Naftifine 2% cream in patients with superficial fungal skin infection

Naftifine hydrochloride, an allylamine, is a topical agent used in treating superficial fungal infections, especially dermatophytosis. The objective of this study was to assess the safety and effectiveness of naftifine 2% cream in Indian patients with superficial fungal skin infection. A real-world observational study to evaluate the safety & effectiveness of Naftifine 2% cream in patients with superficial fungal skin infection. It was an open-label, multi-centric, observational, prospective real-world study conducted on Indian patients, where subjects were advised to apply naftifine 2% cream on the affected area at the discretion of the treating physician. Effectiveness was determined by assessing the clinical cure (absence of signs and symptoms) and/or mycological cure (negative microscopic KOH test) at the end of the treatment. Safety & tolerability were evaluated based on the presence of adverse events and their severity. The patient compliance was recorded based on the investigator's assessment. A total of 463 patients were enrolled in the study, out of which 82.07% achieved a clinical cure at the end of the treatment. The skin scraping for microscopic KOH mounting was available for 94 patients out of which the mycological cure was observed in 89 patients (94.6%) (p<0.0001) at the end of the treatment. Our study recorded a lower incidence of adverse events (2.4%), commonly including dermatitis, pruritis, skin irritation at the application site, and erythema. The reported adverse events were mild or moderate and were cured within 2-7 days. The naftifine 2% cream was well tolerated by 70.8% of the patients. Upon completion of the treatment, 296 patients (64.1%) exhibited 100% compliance to the study drug. Topical Naftifine 2% cream was safe and effective in Indian patients with tinea cruris and tinea corporis.