Eberconazole cream: topical and general tolerability, sensitisation potential, and systemic availability

Area of Science:

• Dermatology
• Pharmacology
• Mycology

Background:

• Eberconazole is a topical imidazole antifungal with demonstrated in vitro and in vivo potency against dermatophytes and yeasts.
• Previous clinical trials suggest high efficacy and good tolerability of eberconazole against dermatophytes.

Purpose of the Study:

• To evaluate the topical and general tolerability of eberconazole cream.
• To assess the potential for skin sensitization, local availability, and systemic absorption of eberconazole.
• To determine the safety profile of repeated, increasing doses of eberconazole cream.

Main Methods:

• Two clinical trials involving 28 healthy volunteers were conducted.
• Study I assessed topical availability and tolerability using increasing doses of 2% eberconazole cream and placebo, with topical washing assessments.
• Study II evaluated systemic absorption by applying 1% eberconazole cream and monitoring blood and urine samples.

Main Results:

• Mild, transient redness was the only significant local reaction, observed with both eberconazole and placebo.
• Reported side effects were mild and infrequent, with coldness and itching being the most common.
• No signs of skin sensitization or clinically relevant changes in vital signs, ECG, or laboratory parameters were observed.
• Topical availability decreased over time, and plasma and urine concentrations remained below detectable limits.

Conclusions:

• Eberconazole cream exhibits good local and general tolerability.
• The topical antimycotic has acceptable local availability and no detectable systemic absorption.
• Eberconazole cream demonstrates a favorable safety profile with no evidence of skin sensitization.