Naftifine Research Articles

Efficacy of Topical Antifungals in the Treatment of Dermatophytosis

Considering that most randomized controlled trials compare antifungals with placebo instead of other antifungals, conventional meta-analysis is insufficient to define superiority between the evaluated strategies. To our knowledge, this is the first mixed-treatment comparison meta-analysis on antifungal treatments in the literature and shows all the evidence available at the time of the study. To evaluate and compare the efficacy of topical antifungals used in dermatophytosis treatment, using mixed-treatment comparisons. We performed a comprehensive search (up to July 31, 2012) for all entries in MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, Literatura Latino Americana e do Caribe em Ciências da Saúde, and International Pharmaceutical Abstracts. Randomized controlled trials that compared topical antifungals with one another or with placebo in dermatophytosis treatment were selected for analysis. Methodologic quality of the trials was assessed using the Jadad scale. We excluded studies that scored less than 3 points. The outcomes evaluated were mycologic cure at the end of treatment and sustained cure. A random-effects Bayesian mixed-treatment comparisons model was applied to combine placebo-controlled and direct topical antifungals comparison trials. RESULTS Pooled data of the 65 trials identified did not show any statistically significant differences among the antifungals concerning the outcome of mycologic cure at the end of treatment. Regarding the sustained cure outcome, butenafine hydrochloride and terbinafine hydrochloride were significantly more efficacious than were clotrimazole, oxiconazole nitrate, and sertaconazole nitrate. Terbinafine also demonstrated statistical superiority when compared with ciclopirox (ciclopiroxolamine), and naftifine hydrochloride showed better response compared with oxiconazole. No inconsistency was detected in the network of evidence for both outcomes, sustaining the validity of the mixed-treatment comparisons results. With the outcome mycologic cure at the end of treatment, there was no significant difference among the antifungals. Butenafine, naftifine, and terbinafine might be the best strategies for maintaining cured status. Because of the different costs of the antifungals, pharmacoeconomic analysis is required to identify the most efficient strategy for dermatophytosis management.

Naftifine hydrochloride gel 2% is efficacious and safe for the treatment of tinea pedis: Results from a randomized, multicenter, double-blind, vehicle-controlled study

Naftifine hydrochloride gel 2% is efficacious and safe for the treatment of tinea pedis: Results from a randomized, multicenter, double-blind, vehicle-controlled study

Naftifine hydrochloride gel 2% is effective as a topical therapy for moccasin-type tinea pedis

Naftifine hydrochloride gel 2% is effective as a topical therapy for moccasin-type tinea pedis

Accelerated killing of dermatophytes: A direct result of increases in naftifine hydrochloride concentrations

Accelerated killing of dermatophytes: A direct result of increases in naftifine hydrochloride concentrations

The efficacy of oral terbinnafine combined with naftifine hydrochloride and ketoconazole cream for tinea manus and tinea pedis

Objective To explore the efficacy of oral terbinnafine combined with naftifine hydrochloride and ketoconazole cream in the treatment of tinea manus and tinea pedis. Methods The efficacy, fungus eradication, treatment satisfaction, acceptance of medical costs, and incidence of adverse reactions were compared between the study group and the control group. Results The efficacy did not differ significantly between the two groups at cessation of medication(z = 1.230, P= 0.218)but was markedly greater in the study group one month after cessation(z= 2.084, P= 0.038)while did not change notably in the control group. The treatment satisfaction was markedly higher in the study group than in the control group(z= 2.094, P= 0.036). There were no significant differences in acceptance of medical costs and incidence of adverse reactions between the two groups. Conclusions Oral terbinnafine combined with naftifine hydrochloride and ketoconazole cream is safe and effective in the treatment of tinea manus and tinea pedis. Key words: Terbinnafine; Naftifine hydrochloride and ketoconazole cream; Tinea manus and tinea pedis; Mycology

A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream, naftifine hydrochloride 1% cream, and placebo in tinea pedis

A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream, naftifine hydrochloride 1% cream, and placebo in tinea pedis

An open-label study of naftifine hydrochloride 1% gel in the treatment of tinea versicolor

Tinea versicolor (TV) is a superficial cutaneous fungal infection characterized by cutaneous pigment changes, pruritus, scaling, and erythema. This open-label, single-center pilot study evaluated the efficacy and safety of naftifine 1% gel applied twice daily for 2 weeks in 10 men and women (median age 38 years) with TV. Baseline mycology status was determined by potassium hydroxide (KOH) and microscopy and clinical symptom severity (CSS) scored by the investigator using a 0 to 9 scale (0=absent, 9=worst). Patients applied naftifine HCI 1% gel to the affected area twice daily for 14 days. They returned for follow-up efficacy and safety assessments at the end of treatment (week 2), 2 weeks after treatment (week 4), and 6 weeks after treatment (week 8). All patients had a positive mycology at baseline; one was KOH negative at week 2, two were negative at week 4, and five (50%) were negative at week 8. Mean investigator total CSS score decreased from a baseline value of 4.7 to 3.2 at week 2 (32% improvement), 2.6 at week 4 (45% improvement), and 2.7 at week 8 (43% improvement). The patients rated their symptoms to be improved at all follow-up visits. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel is a safe and efficacious topical treatment for TV.

An open-label study of naftifine hydrochloride 1% gel in the treatment of seborrheic dermatitis of the scalp

An open-label study of naftifine hydrochloride 1% gel in the treatment of seborrheic dermatitis of the scalp

A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream and placebo applied daily for 2 weeks in patients with tinea cruris

A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream and placebo applied daily for 2 weeks in patients with tinea cruris

Spectroscopic characterisation of the inclusion complexes between the antifungal drugs naftifine and terbinafine and cyclodextrins

The complexation of naftifine (NF) and terbinafine (TB) with cyclodextrins (CDs) has been investigated by UV/visible and 1H NMR spectroscopy, ROESY techniques and also ESI-MS. Both drugs form 1:1 inclusion complexes with all the CDs tested except with α-CD, as deduced from the Benesi–Hildebrand plots and confirmed by ESI-MS and NMR spectroscopy (Job plot method). The K 11 values for NF decrease in the order β-CD > methylated β-CD > 2-hydroxypropyl-β-CD >γ-CD. The determination of the enthalpy and entropy provides information about the main driving forces in the process. The stability constants of the complexes NF–β-CD, TB–β-CD and TB–γ-CD determined by 1H NMR spectroscopy are in agreement with the values obtained by UV. For TB–β-CD, the value is higher, due to the fact that the length of the TB aliphatic chain allows a deeper inclusion of the naphthalene group inside the corresponding β-CD molecule, according to the 2D ROESY experiments.

Development of Naftifine Hydrochloride Alcohol-Free Niosome Gel

Marketed topical gels of the antifungal drug naftifine hydrochloride contain 50% alcohol as cosolvent. Repeated exposure to alcohol could be detrimental to skin. The aim of this study is to develop an alcohol-free niosome gel containing 1% naftifine hydrochloride. Niosomes were prepared and formulation variables were optimized to achieve maximum entrapment coupled with stability. Maximum drug entrapment and niosome stability entailed imparting a negative charge to the vesicles where entrapment efficiency reached 50%. Niosomes were incorporated into a hydroxyethylcellulose gel. The final gel contained a total drug concentration of 1% (wt/wt) half of which was entrapped in the niosomes. The results suggest the potential usefulness of the niosome gel.

Seborrheic dermatitis flare in a Dutch male due to commensalMalassezia furfurovergrowth

This is a case of seborrheic dermatitis (SD) barbae from which Malassezia furfur (M. furfur) was isolated. The patient was a 57-year-old Dutch male, who was hospitalized for fever and weakness of extremities. He presented with symmetrical erythema with an abundance of greasy chaffy scales on his beard area. No reasons were detected for his fever following a routine search. M. furfur was identified through mycological examination, including direct microscopic examination, culture, Tween test, esculine splitting test and DNA sequencing, of samples from the skin lesions. The patient was treated with oral itraconazole capsules (200 mg, b.i.d. for 8 days, then 200 mg o.d. for 13 days), washing his scalp and face with 2% ketoconazole shampoo (once a day) and topical application of a cream containing 1% naftifine hydrochloride and 0.25% ketoconazole (b.i.d.). After treatment the fever subsided and the SD lesion gradually healed. M. furfur was not isolated again from skin scrapings and 7 days later therapy was terminated and no recurrence was noted after one week follow-up since the cessation of treatment.

Characterization of Complexes Between Naftifine and Cyclodextrins in Solution and in the Solid State

Naftifine (NF) is an antifungal drug poorly soluble in basic aqueous solutions. Complexation with cyclodextrins (CDs) improves the physicochemical characteristics of many drugs. The aim of this work is to characterize the interactions between NF and alpha-CD, beta-CD, hydroxypropylbeta-CD, methylbeta-CD, and gamma-CD. The studies have been developed in pH 12 aqueous solutions at 25 degrees C and in the solid state. The apparent stability constants of the complexes have been determined from phase-solubility diagrams. In the solid state, crystalline and amorphous complexes have been characterized using X-ray diffraction patterns, thermal analysis, and Fourier transform infrared spectroscopy. The solubility of NF improves with all the CDs studied, with the exception of alpha-CD. Different types of diagrams have been found depending on the CD used. The interaction between NF and hydroxypropylbeta-CD is stronger than that with beta-CD due to the specific properties of the substituents. The coevaporation method can be said the best method in preparing the solid complexes, except for NF-alpha-CD; again, there is no evidence of complexation. Furthermore, the presence of different types of CD structures upon complexation (i.e., cage or channel) has been discussed. Dissolution rate studies have been performed, and a positive influence of complexation in the solid state has been observed.

Effect of naftifine on neutrophil adhesion.

Effective methods of fungal treatment involve reduction in fungal infections and host inflammatory responses. Naftifine (NF), a topical antifungal agent, is highly active in vitro and in vivo against a wide range of pathogenic fungi. Additionally NF has been shown to inhibit polymorphonuclear leukocyte (PMN) chemotaxis and respiratory burst activity in an irreversible dose-dependent and time-dependent manner. Since leukocyte adherence to endothelia is believed to be one of the initial crucial events in the recruitment of circulating leukocytes to the site of inflammation, we have investigated the in vitro effect of NF on PMN adherence to nylon fiber, BSA-coated glass chamber or polystyrene, and endothelial monolayers via three adherence assays. All three assays demonstrated a statistically significant reduction (p < 0.01-0.001) in PMN adherence to the respective media. In particular, NF (at 30-60 micrograms/ml) significantly inhibited PMN adherence to endothelial monolayers (p < 0.01) as measured spectrophotometrically by the uptake of rose bengal stain. Therefore, NF inhibits PMN adherence to endothelia in our in vitro model system. This inhibition may constitute part of the anti-inflammatory effect of NF.

Modification of neutrophil functions by naftifine.

Naftifine (NF), a topical antimycotic agent, is highly active in vitro and in vivo against a wide range of pathogenic fungi. NF inhibits human polymorphonuclear leucocyte (PMN) chemotaxis. Following stimulation with zymosan-activated serum, 85-97% of the PMNs exhibited detectable membrane ruffling and polarity. In contrast, NF-treated PMNs did not exhibit such chemotactic factor-induced shape changes. We also analysed the effect of NF on PMN superoxide anion (O2-) and chemiluminescence (CL) production, as a measure of respiratory burst activity. Stimulation of PMNs pre-incubated with NF (37 degrees C for 30 min at 1-150 micrograms/ml) by FMLP, PMA and zymosan resulted in a dose-dependent inhibition in PMN CL. Doses of NF which depressed chemotaxis, inhibited CL and diminished O2- production in a statistically significant manner (P < 0.05-0.001). In conclusion, NF alters membrane-related responses in PMNs, and this alteration may be associated with a change in PMN morphology. Binding of NF to PMN membrane sterol, with a subsequent alteration in membrane configuration, is the most likely cause of the inhibition of PMN function. The data collectively document biochemical and morphological differences between control and NF-treated PMNs as determined by stimulus-specific CL and O2- generation and membrane shape change. Such differences may account, in part, for its efficacy in inflammatory fungal skin diseases.

Naftifine (Naftin) in Pediatrics

To the Editor.— We recently examined two children with tinea corporis who were unresponsive to naftifine therapy. Fungal cultures grew Trichophyton tonsurans and their clinical lesions subsequently cleared with clotrimazole. This experience and the presence of naftifine advertisements in Pediatrics (March 1992) prompted us to share information regarding this medication with fellow pediatricians. Naftifine hydrochloride (Naftin) 1% cream, an allylamine antifungal agent, the first of its kind available in the United States, has been reported to be highly effective in the treatment of tinea pedis, tinea cruris, and tinea corporis.

Naftifine Treatment of Trichomycosis Pubis

Naftifine hydrochloride 1% cream is a recently developed material of proven efficacy in superficial cutaneous fungal infections. The drug has also been reported to have significant antibacterial properties as well. A case of trichomycosis pubis, a bacterial disorder that can easily be mistaken for several fungal diseases, responded to application of naftifine cream. The authors suggest that this medication may be the drug of choice when the clinical presentation consists of nodules encircling pubic or axillary hair.

Comparison of once- and twice-daily naftifine cream regimens with twice-daily clotrimazole in the treatment of tinea pedis

1. Steere AC, Malawista SE, Bartcnhagen NR, et al. The clinical spectrum and treatment of Lyme disease. Yale J Bioi Med 1984;57:453-61. 2. Berger BW. Erythema chronicum migrans of Lyme disease. Arch DermatoI1984;120:1017-21. 3. Kramer N, Rickert RR, Brodkin RH, et al. Septal panniculitis as a manifestation of Lyme disease. Am J Med 1986; 81:149-52. 4. Eichenfield AR, Goldsmith DP, Benach JL, et al. Childhood Lyme arthritis: experience in endemic area. J Pediatr 1986;109:753-8. 5. Russell H, Sampson JS, Schmid GP, et al. Enzyme-linked immunosorbent assay and indirect immunofluorescence assay for Lyme disease. ] Infect Dis 1984;149:465-70. 6. Duffy J, Mertz LE, Wobig GH, et al. Diagnosing Lyme disease: the contribution of serologic testing. Mayo Clin Proc 1988;63: 1116-21. 7. Gammon WR. Urticarial vasculitis. Dermatol Clin 1985; 3:97-105. 8. Monroe EW, Schulz CI, Maize JC, et al. Vasculitis in chronic urticaria: an immunopathologic study. J Invest DcrmatoI1981;76:103-7. 9. Midgard R, Hofstad R. Unusual manifestations of nervous system Borrelia burgdorferi infection. Arch Neurol J987; 44:781-3. 10. Camponovo F, Meier C. Neuropathy of vasculitic origin in a case of Garin-Boujadoux-Bannwarth syndrome with positive Borrelia antibody response. J Ncurol 1986;233: 69-72.