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Naftifine

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1. Naftin (naftifine hydrochloride) Gel

Naftin (naftifine hydrochloride) Gel Drug Approval Package: Naftin (naftifine hydrochloride) NDA #204286 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Naftin (naftifine hydrochloride) Gel, 2% Company: Merz Pharmaceuticals, LLC Application No.: 204286 Approval Date: 06/27/2013 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF

2013 FDA - Drug Approval Package

2. Design of Two Alternative Routes for the Synthesis of Naftifine and Analogues as Potential Antifungal Agents Full Text available with Trip Pro

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 16 and 20 in good to excellent yields, mediated by Mannich-type reactions as the key step of the processes. In these approaches, the γ-aminoalcohols 15 and 19 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 16 and 20. The antifungal assay results showed that intermediates 18 (bearing both a β-aminoketo- and N-methyl functionalities in their structures) and products 20 were the most active. Particularly, structures 18b, 18c, and the allylamine 20c showed the lowest MIC values, in the 0.5-7.8 µg/mL range, against the dermatophytes Trichophyton rubrum

2018 Molecules : A Journal of Synthetic Chemistry and Natural Product Chemistry

3. Reversible naftifine-induced carotenoid depigmentation in Rhodotorula mucilaginosa (A. Jörg.) F.C. Harrison causing onychomycosis Full Text available with Trip Pro

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 biosynthetic pathway, producing depigmentation of R. mucilaginosa in solid and liquid media. Furthermore, depigmentation was a reversible process; naftifine-treated yeast cells that were depigmented

2017 Scientific reports

4. Naftifine

Naftifine Naftifine Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Naftifine Naftifine Aka: Naftifine , Naftin From Related Chapters (...) II. Indications Resistant dermatophyte infections (e.g. ) III. Preparations: Topical Naftifine HCl 1% (Naftin) IV. Efficacy Effective in refractory cases of superficial s Less effective in V. References Images: Related links to external sites (from Bing) These images are a random sampling from a Bing search on the term "Naftifine." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Cost: Medications naftifine (on 7/20/2016

2018 FP Notebook

5. Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis. (Abstract)

Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis. Tinea corporis is fungal infection of body surfaces other than the feet, groin, scalp, or beard. Naftifine hydrochloride is a topical antifungal of the allylamine class used to treat tinea corporis, 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 (...) cream 2% in the treatment of tinea corporis among pediatric subjects.
At baseline, 231 subjects were randomly assigned 1:1 to naftifine cream 2% (n=116) and vehicle (n=115). Treatment effect consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline, week 2 (end of treatment) and week 3. Efficacy was analyzed in 181 subjects (n=88, naftifine; n=93, vehicle) with a positive baseline dermatophyte culture and KOH for whom

2016 Journal of drugs in dermatology : JDD Controlled trial quality: uncertain

6. Colloidal nanocarriers for the enhanced cutaneous delivery of naftifine: characterization studies and in vitro and in vivo evaluations Full Text available with Trip Pro

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 of fungal infections. Nanosized colloidal carriers have gained great interest during the recent years (...) to serve as efficient promoters of drug penetration into the skin. Microemulsions are soft colloidal nanosized drug carriers, which are thermodynamically stable and isotropic systems. They have been extensively explored for the enhancement of skin delivery of drugs. This study was carried out to exploit 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

2016 International journal of nanomedicine

7. Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one (...) or more studies before adding more. Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02335255 Recruitment Status : Completed First Posted : January 9, 2015 Last Update Posted : September 6, 2018 Sponsor

2015 Clinical Trials

8. BE Study of Naftifine HCL

BE Study of Naftifine HCL BE Study of Naftifine HCL - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. BE Study of Naftifine HCL The safety and scientific validity of this study is the responsibility (...) , prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days). Condition or disease Intervention/treatment Phase Tinea Pedis Drug: Naftifine hydrochloride 2% Drug: Placebo Drug: Naftin® 2% (Naftifine

2015 Clinical Trials

9. Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis

Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02132260 Recruitment Status : Completed First

2014 Clinical Trials

10. In Vitro Antifungal Activity of Naftifine Hydrochloride Against Dermatophytes. Full Text available with Trip Pro

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 (...) in concentrations higher than the MIC for each strain. MICs were determined following each passage. The MIC range against the dermatophyte isolates tested was 0.015 to 1.0 μg/ml, with naftifine hydrochloride being fungicidal against 85% of the Trichophyton species. The time-kill assay showed dose-dependent activity, with the greatest reduction in the numbers of CFU corresponding to the highest drug concentration. There was no increase in MIC for any strains following repeated exposure to naftifine hydrochloride

2013 Antimicrobial Agents and Chemotherapy

11. Naftifine

Naftifine Naftifine Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Naftifine Naftifine Aka: Naftifine , Naftin From Related Chapters (...) II. Indications Resistant dermatophyte infections (e.g. ) III. Preparations: Topical Naftifine HCl 1% (Naftin) IV. Efficacy Effective in refractory cases of superficial s Less effective in V. References Images: Related links to external sites (from Bing) These images are a random sampling from a Bing search on the term "Naftifine." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Cost: Medications naftifine (on 7/20/2016

2015 FP Notebook

12. Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis

Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100 (...) ). Please remove one or more studies before adding more. Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01580891 Recruitment Status : Completed First Posted : April 19, 2012 Last Update Posted

2012 Clinical Trials

13. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. (Abstract)

A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated (...) superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139). J Drugs Dermatol. 2011;10(11):1282-1288.

2011 Journal of drugs in dermatology : JDD Controlled trial quality: uncertain

14. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. (Abstract)

A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch").A total of 334 subjects with T. cruris were (...) enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes

2011 Journal of drugs in dermatology : JDD Controlled trial quality: uncertain

15. CRACKCast E120 – Dermatologic presentations

dermatophytic infection of the skin, hair, and/or nails, usually by the Trichophyton organism. Infections of the body, groin, and extremities usually respond to topical antifungal agents. A number of effective topical antifungal agents are available, including clotrimazole, haloprogin, miconazole, tolnaftate, terbinafine, naftifine, and others. Two or three daily applications of the cream form of any of these preparations result in healing of most superficial lesions in 1 to 3 weeks. Tinea Capitis Tinea

2017 CandiEM

16. Mutation in the Squalene epoxidase gene of <i>Trichophyton interdigitale</i> and <i>Trichophyton rubrum</i> associated with allylamine resistance. Full Text available with Trip Pro

, terbinafine, naftifine, amorolfine, ciclopirox olamine, griseofulvin, and luliconazole. The squalene epoxidase gene was evaluated for mutation (if any) in 15 T. interdigitale and 5 T. rubrum isolates exhibiting high MICs for terbinafine. A T1189C mutation was observed in four T. interdigitale and two T. rubrum isolates. This transition leads to the change of phenylalanine to leucine in the 397th position of the squalene epoxidase enzyme. In homology modeling the mutant residue was smaller than the wild

2018 Antimicrobial Agents and Chemotherapy

17. Topical Antiviral and Antifungal Medications in Pregnancy: A Review of Safety Profiles. (Abstract)

on utilizing topical antiviral and antifungal medications in pregnancy. For antiviral medications, acyclovir and trichloroacetic acid are safe to use in pregnancy. Docosanol, imiquimod and penciclovir are likely safe, but should be utilized as second-line agents. Podofilox and podophyllin resin should be avoided. For antifungal medications, clotrimazole, miconazole and nystatin are considered first-line agents. Butenafine, ciclopirox, naftifine, oxiconazole and terbinafine may be utilized after the above

2017 Journal of the European Academy of Dermatology and Venereology

18. Successful Treatment of Paecilomyces lilacinus Onychomycosis with Efinaconazole and Tavaborole Full Text available with Trip Pro

in the literature and none that were successfully treated. Here we present a case of successfully treated onychomycosis caused by P. lilacinus with efinaconazole and tavaborole in a patient who had failed treatment with oral fluconazole, itraconazole, terbinafine, and topical ciclopirox and naftifine.

2016 Skin appendage disorders

19. Safety and Efficacy of NAFT900 in Children With Tinea Capitis

Study Description Go to Brief Summary: A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis Condition or disease Intervention/treatment Phase Tinea Capitis Drug: Naftifine hydrochloride foam, 3% Drug: Vehicle Phase 2 Detailed Description: This is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of NAFT-900 compared to vehicle in the treatment of tinea capitis (...) in children ≥6 years to <13 years of age. There will be approximately 60 subjects enrolled. Qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments: NAFT-900 (Naftifine hydrochloride foam, 3%) Vehicle Foam The study will consist of up to 6 visits. Subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks Study Design Go to Layout table

2016 Clinical Trials

20. Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot

, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation. Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1) Use of systemic antifungals

2016 Clinical Trials

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