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Mentax (Butenafine Hydrochloride Topical) - Summary

 
 



MENTAX SUMMARY

Mentax® Cream, 1%, contains the synthetic antifungal agent, butenafine hydrochloride. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines.

Mentax® (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare).
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NEWS HIGHLIGHTS

Published Studies Related to Mentax (Butenafine Topical)

Comparative efficacy of topical 1% butenafine and 1% clotrimazole in tinea cruris and tinea corporis: a randomized, double-blind trial. [2005]
Localized tinea cruris and tinea corporis can be treated by topical imidazoles (clotrimazole) or newer topical agents like butenafine, a benzylamine derivative with fungicidal activity. The therapeutic efficacy of these two agents was compared in this study... However, this difference was not statistically significant at 4 and 8 weeks of treatment.

Efficacy and safety of butenafine in superficial dermatophytoses (tinea pedis, tinea cruris, tinea corporis). [2001.05]
Superficial dermatophytoses of skin are very common infections seen in clinical practice. Besides topical imidazoles, triazoles and allylamines, topical butenafine (a benzylamine derivative) is a novel agent with broad antifungal activity...

The antifungal agent butenafine manifests anti-inflammatory activity in vivo. [1999.08]
BACKGROUND: Dermatophyte infections are often accompanied by a striking inflammatory reaction, alleviation of which has often been achieved by the concomitant but controversial use of topical steroidal agents. Recent investigations have suggested the presence of inherent anti-inflammatory properties associated with certain antifungal agents, particularly those within the allylamine class. Butenafine, the first and only approved representative of the benzylamine antifungals, possesses a chemical structure and antifungal activity similar to the allylamines. Although several studies have demonstrated excellent antimycotic efficacy, none has addressed anti-inflammatory properties associated with butenafine. OBJECTIVE: This study was designed to determine whether butenafine, a benzylamine antifungal, expresses anti-inflammatory activity in vivo... CONCLUSION: The benzylamine antifungal agent butenafine demonstrates inherent anti-inflammatory properties, in vivo, as demonstrated by reduced cutaneous erythema response after UVB irradiation.

Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream. [1999.04]
The prevalence of onychomycosis, a superficial fungal infection that destroys the entire nail unit, is rising, with no satisfactory cure. The objective of this randomized, double-blind, placebo-controlled study was to examine the clinical efficacy and tolerability of 2% butenafine hydrochloride and 5% Melaleuca alternifolia oil incorporated in a cream to manage toenail onychomycosis in a cohort...

Management of toenail onychomycosis with 2% butenafine and 20% urea cream: a placebo-controlled, double-blind study. [1998.10]
Onychomycosis is an increasingly common and recalcitrant fungal nail infection world-wide. The purpose of this placebo-controlled, double-blind study was to determine the clinical efficacy, chemical avulsion, and tolerability of 2% butenafine hydrochloride and 20% urea incorporated in a cream to cure toenail onychomycosis in a preselected population...

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Clinical Trials Related to Mentax (Butenafine Topical)

Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis [Completed]
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis [Completed]
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis [Terminated]
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

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Page last updated: 2006-11-04

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