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Ecoza

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Ecoza

CLINICAL PHARMACOLOGY

Mechanism of Action

Ecoza topical foam is an azole antifungal.

Pharmacodynamics

The pharmacodynamics of Ecoza topical foam, 1% have not been established.

Pharmacokinetics

The systemic absorption of Ecoza topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects.

In the adult trial, 19 subjects (male and female) with tinea pedis applied Ecoza topical foam, 1% once daily for 29 days. Subjects applied a mean daily amount of 2.4 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application. Results (mean ± SD) showed the time to reach peak plasma concentrations (Tmax) was 6.8 ± 5.1 h with maximum concentration (Cmax) of 417 ± 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC(0-12)) was 3440 ± 1920 pg-h/ml.

In the pediatric trial, 18 subjects (male and female ages 12 -17) with interdigital tinea pedis and positive fungal cultures were treated with Ecoza topical foam, 1% once daily for 4 weeks. Subjects applied a mean daily amount of 3.2 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 28 at pre-dose and 7 h and 11 h post-dose. The mean ± SD econazole plasma concentration was 397 ± 289, 534 ± 745 and 575 ± 638 pg/mL at pre-dose and 7 h and 11 h post-dose, respectively.

Microbiology

Mechanism of Action

Econazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole. Mammalian cell demethylation is less sensitive to econazole inhibition.

Activity in vitro and in clinical infections

Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [see INDICATIONS AND USAGE].

Trichophyton rubrum
Epidermophyton floccosum
Trichophyton mentagrophytes

Clinical Studies

In two multi-center, randomized, double-blind, vehicle-controlled clinical trials a total of 505 subjects with interdigital tinea pedis were randomized 1:1 to Ecoza topical foam or vehicle; subjects applied the assigned medication once daily for 4 weeks. The severity of erythema, scaling, fissuring, maceration, vesiculation, and pruritus were graded using a 4-point scale (none, mild, moderate, severe). Subjects had KOH examination and fungal cultures taken to confirm eligibility. A total of 339 subjects with positive fungal cultures were evaluated for efficacy. Efficacy was evaluated on Day 43, 2 weeks post-treatment with treatment success being defined as complete cure (negative KOH and fungal culture and no evidence of clinical disease). The study population ranged in age from 12 to 71 years with 3 subjects less than 18 years of age at baseline. The subjects were 71% male and 52% Caucasian. Table 1 presents the efficacy results for each trial.

Table 1: Efficacy Results at Two Weeks Post-treatment (Day 43) Complete Cure, Effective Treatment and Mycological Cure

  Trial 1 Trial 2
Ecoza topical foam, 1%
N = 82
n(%)
Foam Vehicle
N = 83
n(%)
Ecoza topical foam, 1%
N = 91
n(%)
Foam Vehicle
N = 83
n(%)
Complete curea 19 (23.2%) 2 (2.4%) 23 (25.3%) 4 (4.8%)
Effective treatmentb 40 (48.8%) 9 (10.8%) 44 (48.4%) 9 (10.8%)
Mycological curec 56 (68.3%) 13 (15.7%) 61 (67.0%) 15 (18.1%)
aMycological cure and an absence of clinical signs and symptoms (erythema, scaling, fissuring, maceration, vesiculation, or pruritus).
bMycological cure and no or mild erythema and/or scaling with all other signs and symptoms absent.
cNegative KOH and fungal culture.

Last reviewed on RxList: 11/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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