Spectazole (Econazole Nitrate) - Summary

SPECTAZOLE SUMMARY

SPECTAZOLE
(econazole nitrate 1%)
Cream

SPECTAZOLE Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.

SPECTAZOLE Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

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NEWS HIGHLIGHTS

Published Studies Related to Spectazole (Econazole)

Controlled study on thymol + eugenol vaginal douche versus econazole in vaginal candidiasis and metronidazole in bacterial vaginosis. [2011]
PURPOSE OF THE STUDY: Bacterial vaginosis (BV) and vaginal candidiasis (VC) are usually managed with topical antibiotics. This study compared the efficacy of a thymol + eugenol vaginal douche (SD) (CAS nr. thymol: 89-83-8 and eugenol: 97-53-0), with econazole (CAS 27220-47-9) in VC and metronidazole (CAS 443-48-1) in BV, as suppository reference therapies. Thymol and eugenol are natural antibacterial and antimycotic active ingredients extracted from plants... CONCLUSION: SD was found to be an effective prescription drug in minor recurrent vaginal infectious episodes and its use can reduce the repeated exposure to antibiotics.

Econazole-polycarbophil, a new delivery system for topical therapy: microbiological and clinical results on vaginal candidiasis. [2008.06]
The aim of this study was to demonstrate that the addition of a bioadhesive polymer to econazole, which increases the duration of the active drug at the site of infection, leads to a greater frequency of negative culture after treatment and probably reduces the recurrence rate of vaginal candidiasis.180 women with vaginal candidiasis were treated with 150 mg vaginal ovules econazole nitrate with (group A) or without (group B) polycarbophil.

A randomised clinical trial comparing 2% econazole and 5% natamycin for the treatment of fungal keratitis. [2003.10]
AIM: To compare 2% econazole and 5% natamycin in the management of fungal keratitis... CONCLUSIONS: 2% Econazole appears to be as effective as 5% natamycin for the management of fungal keratitis.

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.

A comparative clinical evaluation of econazole nitrate, miconazole, and nystatin in the treatment of vaginal candidiasis. [2000.01]
A controlled triple open clinical study on three vaginal tablets--Econazole nitrate, Miconazole and Nystatin, was carried out. Seventy-five patients, aged between 18 and 45 years, presenting with mycologically proven cases of vaginal candidiasis, met certain set criteria and were admitted into the study.

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Clinical Trials Related to Spectazole (Econazole)

Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis [Recruiting]
This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.

Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis [Recruiting]
This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.

A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail [Active, not recruiting]
Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will be treated for 48 weeks with lacquer application to at least one affected great toenail. All subjects will receive treatment with EcoNail™ lacquer.

Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M® [Not yet recruiting]
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.

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