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Keywords:

  • pimecrolimus;
  • randomized controlled trial;
  • rosacea

Summary

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.