Tacrolimus: a new option in therapy-resistant chronic external otitis.

OBJECTIVE: To evaluate the efficacy of the novel topical immune modulator tacrolimus in chronic uninfectious otherwise therapy-resistant external otitis (EO).

STUDY DESIGN: Prospective clinical study.

PATIENTS AND METHODS: There were 53 patients aged 5 to 83 years. An ear wick containing 0.1% tacrolimus ointment (Protopic) was inserted into the external auditory canal every 2nd to 3rd day. Altogether, the wick was changed three times. The pre-, intra- and posttherapeutic state of the clinical parameters otalgia, edema, otorrhea, erythema, pruritus, and desquamation was rated by means of a 6-point score system. Treatment efficiency was evaluated on the basis of follow-up investigations at 3-month intervals, a standardized findings sheet, and photograph documentation.

RESULTS: The short-term results showed a clear improvement in 85% of the patients and significant reductions of the severity levels for all clinical parameters investigated (P < .001). Concerning the long-term results, a one-time treatment cycle led to complete healing in 46% of the patients throughout a follow-up of 10 to 22 months. Of the patients, 54% had recurrent EO events with significantly extended mean symptom-free intervals. Reapplied tacrolimus treatment patterns attenuated the relapsing course of disease and significantly reduced the number of EO episodes. Within the observation period, no relevant side effects were observed, except for a local feeling of heat, occasional skin burning, and itching.

CONCLUSIONS: The topical application of 0.1% tacrolimus ointment in the outer ear canal appears to be an effective and well-tolerated new option in corticosteroid-free treatment of chronic therapy-resistant EO.