naftifine
Regulatory sources consulted
Approved indications
- Interdigital tinea pedis caused by susceptible dermatophytes.
Clinical warnings
- For topical use only, not oral, ophthalmic, or intravaginal. Stop if irritation or sensitivity develops. — openFDA Naftin set ID 6645994a-ecb3-277b-e053-2a91aa0a81e5
Adverse events
Common (≥1%)
Application-site reactions
Pregnancy and lactation
Human data are insufficient. During breastfeeding, weigh the benefits of breastfeeding, maternal need, and potential effects on the infant.
Recent literature (PubMed)
Naftifine, an allylamine, is highly effective against tinea pedis and exhibits relatively greater affinity to skin and nail beds, possibly due to its high lipophilicity. To study the efficacy and safety of naftifine 2% gel in an Indian population, a phase III multicentre double-blind, comparative, parallel-group study was conducted in comparison with miconazole 2% gel in patients with interdigital tinea pedis, with mild to moderate symptoms. Patients presenting with mild to moderate signs and symptoms of interdigital tinea pedis and mycologically confirmed tinea infection were randomised to either naftifine hydrochloride 2% gel (n = 112) or miconazole 2% gel (n = 112) in 1:1 ratio. All patients were treated for 2 weeks with a follow-up of up to 12 weeks. Study evaluations were done at the end of 2, 6, and 12 weeks. The primary efficacy endpoint was the proportion of patients achieving clinical cure at week 6 (± 4 days) and secondary endpoints were the mycological cure at week 6 and week 12 and complete cure at week 12. At the end of week 6, clinical cure was 54.55% and 50.00% in the naftifine and miconazole groups (p = 0.4960), respectively, and it was increased to 78.18% and 76.36% in the naftifine and miconazole group (p = 0.7455) at the end of week 12. Mycological and clinical cure were similar in the naftifine and miconazole groups at week 6 and week 12. The safety and tolerability profiles of both treatments were similar. Naftifine 2% gel was efficacious and safe for the treatment of mild to moderate interdigital tinea pedis. Its clinical effectiveness was comparable to that of miconazole 2% gel. Clinical Trials Registry of India: CTRI/2021/01/030753.
Allylamines, naftifine and terbinafine, and the benzylamine, butenafine, are antifungal agents with activity on the fungal cell membrane. These synthetic compounds specifically inhibit squalene epoxidase, a key enzyme in fungal sterol biosynthesis. This results in a deficiency in ergosterol, a major fungal membrane sterol that regulates membrane fluidity, biogenesis, and functions, and whose damage results in increased membrane permeability and leakage of cellular components, ultimately leading to fungal cell death. With the fungal cell membrane being predominantly made up of lipids including sterols, these lipids have a vital role in the pathogenesis of fungal infections and the identification of improved therapies. This review will focus on the fungal cell membrane structure, activity of allylamines and benzylamines, and the mechanistic damage they cause to the membrane. Furthermore, pharmaceutical preparations and clinical uses of these drugs, mainly in dermatophyte infections, will be reviewed.
Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis (ringworm), and tinea cruris (jock itch), are widespread fungal infections that significantly impact global health and quality of life. Naftifine, an allylamine antifungal agent, is noted for its potent fungicidal activity, targeting fungal cell membranes by inhibiting squalene epoxidase. Additionally, Naftifine has anti-inflammatory and antibacterial properties, enhancing its therapeutic potential. This systematic review and meta-analysis aims to comprehensively evaluate the efficacy and safety of Naftifine in treating tinea pedis, tinea corporis, and tinea cruris, focusing on clinical outcomes, cure rates, and adverse effects to provide a thorough understanding of its effectiveness in managing these infections. This meta-analysis followed the PRISMA guidelines and included randomized controlled trials (RCTs) assessing naftifine's efficacy and safety in treating tinea pedis, corporis, and cruris. A systematic search was conducted in major databases from inception until February 9th, 2024. Eligible studies were selected based on predefined inclusion criteria, and data were extracted and analyzed using RevMan software. Seven multicenter RCTs were included in the meta-analysis. Naftifine demonstrated superior efficacy compared to vehicle control in terms of complete cure rate (RR = 5.83, 95% CI [3.73 to 9.10]) with no significant heterogeneity (I2 = 0%), clinical improvement [RR = 1.55, 95% CI (1.21-2.00)], and treatment effectiveness [RR = 3.93, 95% CI (2.44-6.33)] for tinea pedis. Similarly, for tinea corporis and cruris, Naftifine demonstrated significant efficacy compared to vehicle control regarding complete cure rate, mycological cure rate, clinical improvement, and treatment effectiveness. However, there was no significant difference in adverse events between Naftifine and the vehicle across all three conditions. Naftifine is an effective topical treatment for tinea pedis, corporis,
Tinea nigra is a superficial fungal infection usually caused by Hortaea werneckii (H. werneckii). We report a special case of tinea nigra in an immunocompetent child who developed a unilateral, rapidly growing pigmented lesion on her palm. Interestingly, Curvularia lunata (C. lunata) was isolated from the lesion scrapes and was identified by both morphological features and molecular biology methods. The lesion was completely cleared by topical naftifine hydrochloride and ketoconazole cream. We present-to the best of our knowledge-the first case of tinea nigra where the causative pathogen was identified as C. lunata. We therefore provide a brief literature review of previously reported cases of tinea nigra to broaden the knowledge of the potential causative pathogens. The etiology, demography, clinical features, diagnostic methods, and treatment of the reviewed cases are summarized and analyzed.