Addition of pimecrolimus cream 1% to a topical corticosteroid treatment regimen in paediatric patients with severe atopic dermatitis: a randomized, double-blind trial.
BACKGROUND
Pimecrolimus and topical corticosteroids (TCS) combination therapy may provide an alternative treatment for patients with severe atopic dermatitis (AD), with faster clearance of disease flares, consequently reducing the duration of TCS treatment.


OBJECTIVE
To assess the safety profile of pimecrolimus cream 1% combined with fluticasone versus fluticasone alone in paediatric patients with severe AD.


METHODS
Patients (n = 376) were randomized to a combination of pimecrolimus cream 1% with fluticasone or vehicle plus fluticasone for 4 weeks. The primary outcome measure was the frequency of clinically relevant pre-defined adverse events (AEs) associated with the topical use of corticosteroids in patients with severe AD.


RESULTS
Erythematous rash was the only AE, occurring more frequently in the combination group, while there were no noticeable differences in the frequency of other AEs of clinical interest between treatment groups. Efficacy variables were comparable between the two groups. A trend for greater time to relapse was observed for the combination of pimecrolimus cream 1% with fluticasone in patients who were clear at the end of treatment, with a marked improvement in facial AD.


CONCLUSIONS
In paediatric patients with severe AD the overall safety profile of pimecrolimus cream 1% combined with fluticasone was similar to that of fluticasone alone.
Meurer
Michael
M
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie Dresden, Dresden, Germany. meurer@rcs.urz.tu-dresden.de
Eichenfield
Lawrence F
LF
Ho
Vincent
V
Potter
Paul C
PC
Werfel
Thomas
T
Hultsch
Thomas
T
D000287:Administration, Topical; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000175:diagnosis* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D009824:Ointments / Q000627:therapeutic use; D018570:Risk Assessment; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D007166:Immunosuppressive Agents; D009824:Ointments; C117268:pimecrolimus; D000068298:Fluticasone; D016559:Tacrolimus