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.

• Authors: C-Y Chu
• Journal: Journal 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 [Print] England
• PMID: 17373975 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Adrenal Cortex Hormones
• Calcineurin Inhibitors
• Dermatologic Agents
• pimecrolimus
• Tacrolimus

Topics

• Administration, Cutaneous
• Adolescent
• Adrenal Cortex Hormones (adverse effects)
• Adult
• Aged
• Calcineurin 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