KOLOA, HAWAII — Fluocinolone acetonide oil 0.01% ear drops have recently become the first-ever drug to earn a Food and Drug Administration indication for the treatment of chronic eczematous external otitis, Dr. Lawrence F. Eichenfield said at the annual Hawaii Dermatology Seminar sponsored by the Skin Disease Education Foundation.
“It's an issue that dermatologists don't know much about. I learned about it because an [ear, nose, and throat doctor] I work with sent me lots of affected patients,” said Dr. Eichenfield, professor of pediatrics and dermatology at the University of California, San Diego.
FDA approval for use of the medication in adults and children aged 2 years and up was based on a 154-patient clinical trial in which 5 drops per ear twice a day for 7 days of the topical corticosteroid known as DermOtic oil ear drops proved more effective than placebo in clearing the dermatitis.
Dr. Eichenfield has received research funding from Hill Dermaceuticals Inc., which markets DermOtic.