Addition of topical pimecrolimus to once-daily mid-potent steroid confers no short-term therapeutic benefit in the treatment of severe atopic dermatitis; a randomized controlled trial


  • Conflicts of interest
    Funding for this study was provided by Novartis Pharmaceuticals Corporation, East Hanover, NJ, U.S.A.

Jonathan M. Spergel, Division of Allergy and Immunology, Wood Bldg 5314, Children’s Hospital of Philadelphia, 34th and Civic Center Blvd, Philadelphia, PA 19104, U.S.A.


Background  Combination therapy with pimecrolimus cream 1%, a topical calcineurin inhibitor (TCI), and fluticasone propionate cream 0·05% (FP), a mid-potency topical corticosteroid, may have a synergistic effect for treatment of atopic dermatitis (AD) because their mechanism of action differs.

Objectives  To assess the efficacy of concomitant pimecrolimus twice daily/FP once daily vs. vehicle twice daily/FP once daily in patients with severe AD.

Methods  An exploratory, 2-week, double-blind, randomized, within-patient study was conducted (n = 45). Two target areas of similar severity, size and location were assessed. Assessments included the modified Eczema Area and Severity Index (0–12 scale) (primary variable), localized investigator global assessment (0–4 scale) and Patients’ Self-Assessment of Disease Severity (0–4 scale).

Results  Data for all variables were similar for the TCI/FP and vehicle/FP treatments.

Conclusions  The efficacy observed for treatment of severe AD flares with this TCI/FP combination regimen was equivalent to that of vehicle/FP.