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Ertaczo (Sertaconazole Nitrate Topical) - Summary

 
 



ERTACZO SUMMARY

ERTACZO(sertaconazole nitrate) Cream, 2%

ERTACZO® (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.

ERTACZO® (sertaconazole nitrate) Cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum (see CLINICAL STUDIES Section).


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NEWS HIGHLIGHTS

Published Studies Related to Ertaczo (Sertaconazole Nitrate Topical)

Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis. [2011.05]
Sertaconazole is a new antifungal agent. To compare the efficacy and tolerability of sertaconazole and miconazole cream in cutaneous dermatophytosis, this prospective, randomized, multicentric comparative, phase 4 study was undertaken in 260 patients with cutaneous dermatophytosis after approvals from Institutional Ethics Committees...

Safety and efficacy of sertaconazole nitrate cream 2% in the treatment of tinea pedis interdigitalis: a subgroup analysis. [2010.02]
Sertaconazole nitrate is a broad-spectrum antifungal agent indicated in the United States for the treatment of tinea pedis interdigitalis. The objective of this subgroup analysis was to evaluate the safety and efficacy of sertaconazole nitrate cream 2%, specifically in participants with tinea pedis interdigitalis (ie, fungal skin disease of the toe web) of dermatophyte origin...

The safety and efficacy of sertaconazole nitrate cream 2% for tinea pedis. [2006.10]
To determine the safety and efficacy of topical sertaconazole nitrate cream 2% in the treatment of tinea pedis, 2 randomized, multicenter, double-blinded, parallel group, vehicle-controlled studies were conducted. A total of 588 subjects were enrolled, and 383 subjects were randomized to treatment with sertaconazole or vehicle applied twice daily for 4 weeks...

Nail penetration of sertaconazole with a sertaconazole-containing nail patch formulation. [2006]
BACKGROUND AND OBJECTIVE: Sertaconazole, an imidazole antifungal drug, has been proven to have broad and potent antifungal activity. In the present study, the pharmacokinetics of sertaconazole nail patches, developed for treatment of onychodystrophy and onychomycosis, were investigated in healthy volunteers. The objective of the study was to investigate the penetration of sertaconazole into the nail and plasma and the residual sertaconazole concentration in patches after 1 week of application onto the nails... CONCLUSION: By virtue of their positive influence (occlusion) on water and lipid metabolism in dystrophic nails, nail patches should have beneficial therapeutic effects in onychodystrophic conditions. Addition of the antifungal agent sertaconazole adds broad-spectrum antimicrobial activity. In this study, the concentrations of sertaconazole in the nails were shown to be well above the MIC values for pathogenic fungi relevant to onychomycosis. No systemic absorption of the active ingredient was detectable, which should exclude unwanted systemic effects of the drug.

Topical treatment of vaginal candidosis with sertaconazole and econazole sustained-release suppositories. [2000.12]
OBJECTIVE: To compare the efficacy and safety of sertaconazole and econazole sustained-release suppositories in the treatment of vulvovaginal candidosis... CONCLUSION: Single topical administration of sertaconazole and econazole had similar efficacy and safety but the former is associated with a lower rate of mycological recurrence one month after achieving a negative culture.

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Clinical Trials Related to Ertaczo (Sertaconazole Nitrate Topical)

Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females [Recruiting]
The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole will work equally as well with once a day dosing for 4 weeks for athlete's foot.

Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis [Completed]
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis

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Page last updated: 2011-12-09

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