title: Tacrolimus ointment in nickel sulphate-induced steroid-resistant allergic contact dermatitis.
abstract: Tacrolimus ointment is a topical immunomodulator. Currently, there is available evidence regarding the potential use of topical tacrolimus in a range of dermatological disorders. The aim of this study was to evaluate the efficacy and safety of tacrolimus ointment 0.1% for the nickel sulfate-induced steroid-resistant allergic contact dermatitis (ACD). A randomized, double-blind, placebo-controlled, parallel-group study design was performed in a total of 28 patients affected by nickel sulfate-induced steroid-resistant ACD after a 14-day run-in period. Then, the enrolled patients were randomized into two subgroups. Group A was treated with tacrolimus for 14 days and finally observed for a 7-day follow-up period. Group B, instead, was treated with placebo (vehicle). Four major symptoms (erythema, oozing, scaling, and itching) were considered as outcomes during the different phases of the study. In group A, during the treatment period with tacrolimus, a significant improvement was observed in all four considered symptoms. On the other hand, no improvement in symptoms was observed in the placebo-treated group B. Local adverse events in the tacrolimus-treated group, such as burning/itching at the application site, were transient and well tolerated. No patients withdrew because of burning/itching. In our study, tacrolimus ointment 0.1% appeared to be both effective and safe in the treatment of nickel sulfate-induced steroid-resistant ACD.
authors.affiliation: Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Verona, Italy.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Pacor
authors.forename: Gabriele
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Nicola
authors.initials: N
authors.lastname: Martinelli
authors.forename: Pasquale
authors.initials: P
authors.lastname: Mansueto
authors.forename: Simonetta
authors.initials: S
authors.lastname: Friso
authors.forename: Maria Esposito
authors.initials: ME
authors.lastname: Pellitteri
authors.forename: Gaetana
authors.initials: G
authors.lastname: Di Fede
authors.forename: Giovambattista
authors.initials: G
authors.lastname: Rini
authors.forename: Roberto
authors.initials: R
authors.lastname: Corrocher
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000494:pharmacology; D000328:Adult; D017449:Dermatitis, Allergic Contact / Q000188:drug therapy*; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007509:Irritants; D008297:Male; D008875:Middle Aged; D009532:Nickel / Q000009:adverse effects*; D009824:Ointments; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D007509:Irritants; D009824:Ointments; C029938:nickel sulfate; D009532:Nickel; D016559:Tacrolimus