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Ertaczo

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Ertaczo

CLINICAL PHARMACOLOGY

Mechanism Of Action

ERTACZO cream is an azole antifungal.

Pharmacokinetics

In a multiple dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42 -140 cm²; mean, 93 cm²), ERTACZO cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm²). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.

Microbiology

Mechanism of Action

Sertaconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. Ergosterol is a key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.

Activity In Vitro and in Clinical Infections

Sertaconazole nitrate has been shown to be active against isolates of the following microorganisms in clinical infections [see INDICATIONS AND USAGE]:

Trichophyton rubrum
Trichophyton mentagrophytes
Epidermophyton floccosum

Clinical Studies

In two randomized, double-blind, clinical trials, subjects 12 years and older with interdigital tinea pedis applied either ERTACZO cream, 2%, or vehicle, twice daily for four weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (six weeks after beginning therapy), subjects were evaluated for signs and symptoms related to interdigital tinea pedis.

Treatment outcomes are summarized in the table below.

Treatment Outcomes as Percent (%) of Total Subjects

  Trial 1 Trial 2
Sertaconazole Vehicle Sertaconazole Vehicle
Complete Cure* (Primary Efficacy Variable) 13/99 (13.1%) 3/92 (3.3%) 28/103 (27.2%) 5/103 (4.9%)
Effective Treatment** 32/99 (32.3%) 11/92 (12.0%) 52/103 (50.5%) 16/103 (15.5%)
Mycological Cure*** 49/99 (49.5%) 18/92 (19.6%) 71/103 (68.9%) 20/103 (19.4%)
* Complete Cure – Patients who had complete clearing of signs and symptoms and Mycological Cure.
** Effective Treatment – Patients who had minimal residual signs and symptoms of interdigital tinea pedis and Mycological Cure.
*** Mycological Cure – Patients who had both negative microscopic KOH preparation and negative fungal culture.

In clinical trials, complete cure in sertaconazole treated subjects was achieved in 32 of 160 (20%) subjects with Trichophyton rubrum, in 7 of 28 (25%) subjects with Trichophyton mentagrophytes and in 1 of 13 (15%) subjects with Epidermophyton floccosum.

Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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