PMID- 20394491 OWN - NLM STAT- MEDLINE DCOM- 20100727 LR - 20151119 IS - 1471-1753 (Electronic) IS - 0954-6634 (Linking) VI - 21 IP - 3 DP - 2010 May TI - Addition of pimecrolimus cream 1% to a topical corticosteroid treatment regimen in paediatric patients with severe atopic dermatitis: a randomized, double-blind trial. PG - 157-66 LID - 10.3109/09546630903410158 [doi] AB - 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. CONCLUSION: In paediatric patients with severe AD the overall safety profile of pimecrolimus cream 1% combined with fluticasone was similar to that of fluticasone alone. FAU - Meurer, Michael AU - Meurer M AD - Universitatsklinikum Carl Gustav Carus Klinik und Poliklinik fur Dermatologie Dresden, Dresden, Germany. meurer@rcs.urz.tu-dresden.de FAU - Eichenfield, Lawrence F AU - Eichenfield LF FAU - Ho, Vincent AU - Ho V FAU - Potter, Paul C AU - Potter PC FAU - Werfel, Thomas AU - Werfel T FAU - Hultsch, Thomas AU - Hultsch T LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PL - England TA - J Dermatolog Treat JT - The Journal of dermatological treatment JID - 8918133 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Androstadienes) RN - 0 (Immunosuppressive Agents) RN - 0 (Ointments) RN - 7KYV510875 (pimecrolimus) RN - CUT2W21N7U (Fluticasone) RN - WM0HAQ4WNM (Tacrolimus) SB - IM MH - Administration, Topical MH - Adrenal Cortex Hormones/therapeutic use MH - Androstadienes/*therapeutic use MH - Dermatitis, Atopic/*diagnosis/*drug therapy MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Female MH - Fluticasone MH - Follow-Up Studies MH - Humans MH - Immunosuppressive Agents/*therapeutic use MH - Male MH - Ointments/therapeutic use MH - Risk Assessment MH - Severity of Illness Index MH - Tacrolimus/*analogs & derivatives/therapeutic use MH - Treatment Outcome EDAT- 2010/04/17 06:00 MHDA- 2010/07/28 06:00 CRDT- 2010/04/17 06:00 PHST- 2010/04/17 06:00 [entrez] PHST- 2010/04/17 06:00 [pubmed] PHST- 2010/07/28 06:00 [medline] AID - 10.3109/09546630903410158 [doi] PST - ppublish SO - J Dermatolog Treat. 2010 May;21(3):157-66. doi: 10.3109/09546630903410158.