Document Detail

Topical tacrolimus treatment for chronic dermatitis of the ear.
MedLine Citation:
PMID:  17673384     Owner:  NLM     Status:  MEDLINE    
Recurrent exacerbation in chronic recalcitrant external otitis (EO) often warrants multidisciplinary treatment and collaboration with a dermatologist. The aim of this pilot study was to ascertain the efficacy of topical tacrolimus ointment application in chronic, non-infectious and therapy-resistant EO. In a prospective clinical study, the efficacy of tacrolimus ointment 0.1% was examined in 53 patients with therapy-refractory chronic EO of confirmed non-infectious etiology. Clinical examination took place prior to treatment (V1), at the end (V2) and during follow-up investigations (V3) of 28 patients over 10-22 months. Patients were evaluated for the symptoms otalgia, edema, otorrhea, erythema, pruritus and desquamation on a 6-point scale. The short-term results after topical application of tacrolimus (V2) showed a clear improvement in 85% of the patients (N = 45) and significant drop in severity scores for all clinical parameters (p < 0.001). The long-term follow-up studies (V3) revealed that a one-time treatment cycle led to complete remission in 46% of patients (N = 28). The remaining 54% had recurrent EO events, however, with significantly longer symptom-free intervals. Within the observation period, no relevant local or systemic side effects were observed, except for occasional skin burning, stinging, or itching. This interdisciplinary study between dermatologists and ENT specialists clearly demonstrates that the topical application of 0.1% tacrolimus ointment is an effective and well-tolerated new option in the treatment of chronic recalcitrant EO. Furthermore, it shows that dermatologists, with their experience in topical immunomodulatory therapy, can make valuable contributions to the treatment of inflammatory disorders in other medical fields.
Wolfgang Harth; Philipp P Caffier; Babak Mayelzadeh; Heidemarie Haupt; Benedikt Sedlmaier; Gabriele Richard
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Publication Detail:
Type:  Clinical Trial; Journal Article     Date:  2007-08-02
Journal Detail:
Title:  European journal of dermatology : EJD     Volume:  17     ISSN:  1167-1122     ISO Abbreviation:  Eur J Dermatol     Publication Date:    2007 Sep-Oct
Date Detail:
Created Date:  2007-09-04     Completed Date:  2008-01-31     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  9206420     Medline TA:  Eur J Dermatol     Country:  France    
Other Details:
Languages:  eng     Pagination:  405-11     Citation Subset:  IM    
Clinic for skin diseases, Vivantes Klinikum Berlin Friedrichshain, Department of Dermatology and Phlebology, Landsberger Allee 49, 10249 Berlin, Germany.
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MeSH Terms
Administration, Topical
Aged, 80 and over
Analysis of Variance
Bacterial Infections / chemically induced
Child, Preschool
Dermatitis / drug therapy*,  pathology
Ear, External / pathology
Follow-Up Studies
Immunosuppressive Agents / administration & dosage*,  adverse effects
Middle Aged
Otitis Externa / drug therapy*,  pathology
Severity of Illness Index
Tacrolimus / administration & dosage*,  adverse effects
Treatment Outcome
Reg. No./Substance:
0/Immunosuppressive Agents; 109581-93-3/Tacrolimus

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