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

Abstract 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.