An open-label pilot study to evaluate the safety and efficacy of topically applied pimecrolimus cream for the treatment of steroid-induced rosacea-like eruption.

摘要

Background Steroid-induced rosacea-like eruption is characterized by facial rosacea-like dermatitis in patients that have been treated with topical steroids for relatively long periods. Objective To evaluate the efficacy and tolerability of 1% pimecrolimus topical cream for steroid-induced rosacea-like eruption. Methods In an open-label pilot study, 40 patients were enrolled and instructed to apply 1% pimecrolimus cream twice daily for 6 weeks. Patients were evaluated by a rosacea clinical score, investigator's global assessment, overall erythema severity, and tolerability at weeks 0, 2, and 6. Results In 35 patients, the rosacea clinical score decreased significantly from 16.0 +/- 4.3 at baseline to 8.1 +/- 3.3 at week 2 and 4.2 +/- 2.5 at week 6 (P < 0.0001). Investigator's global assessment was 4.1 +/- 1.1 (baseline), then decreased to 1.4 +/- 0.8 (week 2) and 0.5 +/- 0.6 (week 6) (P < 0.0001). By week 6, 48.6% of the patients were clear. Overall erythema severity was 2.4 +/- 0.7 (baseline), 0.9 +/-0.4 (week 2), and 0.3 +/- 0.4 (week 6) (P < 0.0001). Cutaneous adverse events (local burning, stinging, and itching) occurred in 17.5%. Conclusion Pimecrolimus cream might be efficacious, safe, and well tolerated for steroid-induced rosacea-like eruption. The small sample size and open label nature of this study is its limitation. Further double-blind, vehicle-controlled studies are needed.