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
Journal
Journal of the European Academy of Dermatology and Venereology
Journal Volume
21
Journal Issue
4
Pages
484-490
Date Issued
2007
Author(s)
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 anopen-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. ? 2007 The AuthorJournal compilation ? 2007 European Academy of Dermatology and Venereology.
SDGs
Other Subjects
corticosteroid; fluorinated steroid; pimecrolimus; adolescent; adult; aged; article; burning sensation; clinical assessment; cream; disease severity; drug efficacy; drug induced disease; drug safety; drug tolerability; drug withdrawal; erythema; female; human; male; open study; pilot study; priority journal; pruritus; rosacea; sample size; scoring system; skin manifestation; steroid therapy; treatment duration; Administration, Cutaneous; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Calcineurin; Dermatologic Agents; Drug Eruptions; Erythema; Facial Dermatoses; Female; Follow-Up Studies; Humans; Male; Middle Aged; Patient Satisfaction; Pilot Projects; Rosacea; Safety; Tacrolimus; Telangiectasis; Treatment Outcome
Type
journal article