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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR NAFTIFINE HYDROCHLORIDE

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Clinical Trials for Naftifine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00253305 Topical Gel Anti-Fungal Agent for Tinea Unguium Completed MediQuest Therapeutics Phase 2 The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis). The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety. Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
NCT01580891 Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Completed Taro Pharmaceuticals USA Phase 1 The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
NCT01712360 Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Completed Merz Pharmaceuticals, LLC Phase 4 This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
NCT02132260 Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis Completed Taro Pharmaceuticals USA Phase 1 The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.
NCT02227290 Pediatric Subjects With Tinea Corporis Completed Merz Pharmaceuticals, LLC Phase 4 The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
NCT02335255 Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Completed Taro Pharmaceuticals USA Phase 1 To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Naftifine Hydrochloride

Condition Name

Condition Name for Naftifine Hydrochloride
Intervention Trials
Tinea Pedis 5
Tinea Corporis 2
Tinea Cruris 1
Tinea Capitis 1
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Condition MeSH

Condition MeSH for Naftifine Hydrochloride
Intervention Trials
Tinea 8
Tinea Pedis 5
Tinea Capitis 1
Onychomycosis 1
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Clinical Trial Locations for Naftifine Hydrochloride

Trials by Country

Trials by Country for Naftifine Hydrochloride
Location Trials
United States 19
Dominican Republic 5
Honduras 3
Puerto Rico 1
Panama 1
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Trials by US State

Trials by US State for Naftifine Hydrochloride
Location Trials
Texas 3
Missouri 3
Florida 3
Oregon 2
Arizona 2
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Clinical Trial Progress for Naftifine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Naftifine Hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Naftifine Hydrochloride
Clinical Trial Phase Trials
Completed 8
Withdrawn 1
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Clinical Trial Sponsors for Naftifine Hydrochloride

Sponsor Name

Sponsor Name for Naftifine Hydrochloride
Sponsor Trials
Merz Pharmaceuticals, LLC 4
Taro Pharmaceuticals USA 3
Semler Research Center Pvt. Ltd. 1
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Sponsor Type

Sponsor Type for Naftifine Hydrochloride
Sponsor Trials
Industry 9
Other 1
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