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)

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.

Multi-centre double-blind trial on the efficacy and safety of sertaconazole 2% cream in comparison with miconazole 2% cream on patients suffering from cutaneous mycoses. [1992.05]
The efficacy and tolerance of 7-chloro-3-[1-(2,4-dichlorophenyl)-2- (1H-imidazol-1-yl)ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) 2% dermatological cream in two daily applications compared with miconazole 2% cream in two daily applications were studied on 631 patients suffering from superficial cutaneous mycosis (sertaconazole n = 317, miconazole n = 314), in a double-blind, controlled multicentre trial with parallel groups...

Therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of Pityriasis versicolor. [1992.05]
The activity of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl) ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32,2) was studied in a randomized parallel double-blind clinical trial on 21 patients suffering from Pityriasis versicolor (confirmed by KOH microscopic examination and exploration with Wood's light)...

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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.

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