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.
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%.


CONCLUSIONS
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.
Chu
C-Y
CY
Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. chiayu.chu@gmail.com
D000279:Administration, Cutaneous; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003875:Drug Eruptions / Q000188:drug therapy* / Q000209:etiology; D004890:Erythema / Q000188:drug therapy; D005148:Facial Dermatoses / Q000139:chemically induced / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D012393:Rosacea / Q000139:chemically induced / Q000188:drug therapy*; D012449:Safety; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013684:Telangiectasis / Q000188:drug therapy; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus