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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.

AbstractBACKGROUND: 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.
AuthorsC-Y Chu (Affiliation: Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. chiayu.chu at gmail.com)
JournalJournal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 21 Issue 4 Pg. 484-90 (Apr 2007) ISSN: 0926-9959 Netherlands
PMID17373975 (Publication Type: Clinical Trial, Journal Article)
Chemical References
  • Adrenal Cortex Hormones
  • Dermatologic Agents
  • pimecrolimus
  • Tacrolimus
  • Calcineurin
Topics
  • Administration, Cutaneous
  • Adolescent
  • Adrenal Cortex Hormones (adverse effects)
  • Adult
  • Aged
  • Calcineurin (antagonists & inhibitors)
  • Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
  • Drug Eruptions (drug therapy, etiology)
  • Erythema (drug therapy)
  • Facial Dermatoses (chemically induced, drug therapy)
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Pilot Projects
  • Rosacea (chemically induced, drug therapy)
  • Safety
  • Tacrolimus (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Telangiectasis (drug therapy)
  • Treatment Outcome