Conflicts of interest M.B. is employed by Novartis Pharma, the manufacturer of Elidel®(pimecrolimus).
Pimecrolimus cream 1% for papulopustular rosacea: a randomized vehicle-controlled double-blind trial
Article first published online: 21 DEC 2006
British Journal of Dermatology
Volume 156, Issue 4, pages 728–732, April 2007
How to Cite
Weissenbacher, S., Merkl, J., Hildebrandt, B., Wollenberg, A., Braeutigam, M., Ring, J. and Hofmann, H. (2007), Pimecrolimus cream 1% for papulopustular rosacea: a randomized vehicle-controlled double-blind trial. British Journal of Dermatology, 156: 728–732. doi: 10.1111/j.1365-2133.2006.07669.x
- Issue published online: 21 DEC 2006
- Article first published online: 21 DEC 2006
- Accepted for publication 27 August 2006
- randomized controlled trial;
Background Rosacea remains difficult to treat, despite many therapeutic options.
Objectives To investigate the effect of pimecrolimus cream 1% (Elidel®; Novartis Pharma, Nuremberg, Germany) in the treatment of papulopustular rosacea.
Methods Forty patients with rosacea (25 men and 15 women, mean age 58 years) were enrolled in a randomized, vehicle-controlled, double-blind study. For 4–8 weeks, patients applied pimecrolimus cream or vehicle twice daily to the involved areas on the face. Rosacea severity score, subjective severity assessment and quality of life assessment were obtained, along with photographic documentation.
Results Both treatment groups of 20 patients showed an improvement after 4 weeks. The differences were not significant (P > 0·05) with regard to mean absolute values, mean percentage changes from baseline, or mean absolute values as differences from baseline for the total score or scores of the different clinical signs (erythema, papulation, scaling and pustules). In the subjective severity score and the quality of life assessment, there was also no significant difference between pimecrolimus and the vehicle (P > 0·05).
Conclusions Treatment of rosacea for 4–8 weeks with the topical calcineurin inhibitor pimecrolimus cream 1% was not more efficacious than treatment with the vehicle cream.