Onset of pruritus relief with pimecrolimus cream 1% in adult patients with atopic dermatitis: a randomized trial
Article first published online: 7 NOV 2005
Volume 61, Issue 3, pages 375–381, March 2006
How to Cite
Kaufmann, R., Bieber, T., Helgesen, A. L., Andersen, B. L., Luger, T., Poulin, Y., Al-Hafidh, J., Paul, C. and the multicentre investigator group (2006), Onset of pruritus relief with pimecrolimus cream 1% in adult patients with atopic dermatitis: a randomized trial. Allergy, 61: 375–381. doi: 10.1111/j.1398-9995.2005.00977.x
- Issue published online: 23 JAN 2006
- Article first published online: 7 NOV 2005
- Accepted for publication 2 August 2005
- atopic dermatitis;
- pruritus relief
Background: Pimecrolimus cream 1% (Elidel, Novartis Pharmaceuticals AG) effectively improves/relieves pruritus associated with atopic dermatitis (AD), but few data are available regarding the timing of relief. The purpose of this study was to investigate the timing of pruritus relief produced with pimecrolimus in adults with mild/moderate AD and moderate/severe pruritus.
Methods: Patients were randomized to 7 days of treatment with pimecrolimus (n = 100) or vehicle (n = 98). Pruritus severity was assessed daily on a 4-point scale (0 = absent, 3 = severe), reflecting the previous 24 h experience. Patients who completed this core study were eligible to enter a voluntary 5-week, open-label extension study.
Results: A significant effect was noted within 48 h of treatment, with pruritus improving in 56% of pimecrolimus-treated patients and 34% of vehicle-treated patients (P = 0.003). Pruritus relief was maintained during the remainder of the core and extension phases, and was accompanied by an improvement in the Investigator's Global Assessment score.
Conclusion: Pimecrolimus cream 1% significantly reduced pruritus within 48 h.