Efficacy and Safety of Naftifine Hydrochloride 2% Gel in Interdigital Tinea Pedis: A Phase III Randomised, Double-Blind, Parallel-Group, Active-Controlled Study in Indian Adult Patients. 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
Naftifine An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationTopical naftifine has not been studied during breastfeeding. Because only 4 to 6% is absorbed after topical application, it is considered a low risk to the nursing infant.[1] Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream, gel or liquid
Naftin (naftifine hydrochloride) Gel Drug Approval Package: Naftin (naftifine hydrochloride) NDA #204286 Drug Approval Package Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links * * * U.S. Food & Drug Administration * Follow FDA * En EspañolSearch FDA * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco ProductsDrug Approval Package * * * * FDA Home * Drugs * Drug Approvals and Databases * Drugs@FDA-Naftin (naftifine hydrochloride) Gel, 2%Company: Merz Pharmaceuticals, LLCApplication No.: 204286Approval Date: 06/27/2013Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. * Approval Letter(s
Design of Two Alternative Routes for the Synthesis of Naftifine and Analogues as Potential Antifungal Agents Two practical and efficient approaches have been implemented as alternative procedures for the synthesis of naftifine and novel diversely substituted analogues and in good to excellent yields, mediated by Mannich-type reactions as the key step of the processes. In these approaches , the γ-aminoalcohols and were obtained as the key intermediates and their subsequent dehydration catalyzed either by Brønsted acids like H₂SO₄ and HCl or Lewis acid like AlCl₃, respectively, led to naftifine, along with the target allylamines and . The antifungal assay results showed that intermediates (bearing both a β-aminoketo- and -methyl functionalities in their structures) and products were
Reversible naftifine-induced carotenoid depigmentation in Rhodotorula mucilaginosa (A. Jörg.) F.C. Harrison causing onychomycosis Rhodotorula mucilaginosa was isolated from a patient with onychomycosis, and identification was confirmed by morphological and cultural characteristics as well as by DNA molecular analysis. Antifungal agents naftifine (10 mg/mL, active substance in Exoderil ) and bifonazole (10 mg/mL, active substance in Canespor) were tested in different concentrations to assess in vitro effects on fungal growth and carotenoid synthesis. The antifungal mechanisms of action of naftifine and bifonazole against R. mucilaginosa isolates were similar and affected the biosynthetic pathway of ergosterol. For the first time, this research demonstrates that naftifine affects the carotenoid
The Role of Naftifine Gel in Tinea Pedis PROSPEROInternational prospective register of systematic reviews Print | PDFThe Role of Naftifine Gel in Tinea PedisEsraa AlEdani, Mohamed Abo zeidTo enable PROSPERO to focus on COVID-19 submissions, this registration record has undergone basic automated checks for eligibility and is published exactly as submitted. PROSPERO has never provided peer review , and usual checking by the PROSPERO team does not endorse content. Therefore, automatically published records should be treated as any other PROSPERO registration. Further detail is provided here.CitationEsraa AlEdani, Mohamed Abo zeid. The Role of Naftifine Gel in Tinea Pedis. PROSPERO 2024 CRD42024511623 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024511623Review
Colloidal nanocarriers for the enhanced cutaneous delivery of naftifine: characterization studies and in vitro and in vivo evaluations In topical administration of antifungals, the drugs should pass the stratum corneum to reach lower layers of the skin in effective concentrations. Thus, the formulation of antifungal agents into a suitable delivery system is important for the topical treatment the feasibility of colloidal carriers as to improve skin transport of naftifine, which is an allylamine antifungal drug. The microemulsions were formulated by construction of pseudoternary phase diagrams and composed of oleic acid (oil phase), Kolliphor(®) EL or Kolliphor(®) RH40 (surfactant), Transcutol(®) (cosurfactant), and water (aqueous phase). The plain and drug-loaded microemulsions were characterized
Naftifine Hydrochloride Gel 2%: An Effective Topical Treatment for Moccasin-Type Tinea Pedis. Naftifine hydrochloride (naftifine) is a topical antifungal of the allylamine class, displaying fungicidal and fungistatic activity. Naftifine is generally used to treat interdigital tinea pedis; however, systemic therapy is often prescribed by healthcare providers for moccasin tinea pedis. Well -controlled clinical data on topical antifungal therapy for moccasin tinea pedis is limited. The objective of this analysis is to present data from two pooled randomized, vehicle-controlled studies that evaluated efficacy of once daily topical naftifine gel 2% and vehicle at end of treatment (week 2) and at 4 weeks post-treatment in subjects with moccasin tinea pedis. At visit 1, subjects were randomized
In Vitro Antifungal Activity of Naftifine Hydrochloride Against Dermatophytes. The incidence of superficial dermatophytoses is high in developed countries, and there remains a need for effective topical antifungals. In this study, we evaluated the in vitro antifungal activity of naftifine hydrochloride, the active ingredient in naftifine hydrochloride cream and gel 1% and 2%, against dermatophytes. The MICs and minimum fungicidal concentrations (MFCs) of naftifine hydrochloride against 350 clinical strains, including Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Epidermophyton floccosum, and Microsporum canis, were determined using the CLSI methodology. Subsets from this test panel were subsequently tested in a time-kill assay at 0.125×, 0.25×, 0.5×, and 1× the MFC for each
Efficacy and Safety of Naftifine HCl Gel 2% in the Treatment of Interdigital and Moccasin Type Tinea Pedis: Pooled Results from Two Multicenter, Randomized, Double-Blind, Vehicle-Controlled Trials. Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti -bacterial and anti-inflammatory effects. To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis. At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated
. A number of effective topical antifungal agents are available, including clotrimazole, haloprogin, miconazole, tolnaftate, terbinafine, naftifine, and others
at the clinic of the Institute of Dermatology and Venereology of the National Academy of Medical Sciences of Ukraine, who were divided into groups: Group I (30 patients) received naftifine hydrochloride solution and cream; Group II (33 patients) additionally used nail kit mycosan and cytoflavin 2 tablets 2 times a day for 1-1.5 months. The study implied microscopic and molecular genetic examination of nail , depending on the severity and clinical form. The overall effectiveness of therapy at the 48th week reached 56.7% in Group I and 72.7% in Group II. Conclusions: The developed method of treatment, which includes the use of naftifine hydrochloride solution and cream, nail kit micozan and cytoflavin, allows to achieve clinical and mycological recovery in 72.7% of patients and is a priority in the treatment