A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis.

Abstract

BACKGROUND:

Perioral dermatitis (POD) is a common dermatosis without standard therapy.

OBJECTIVE:

We sought to evaluate pimecrolimus cream 1% in POD.

METHODS:

We conducted a multicenter, randomized, double-blind, parallel-group study in adult patients with POD treated twice daily with pimecrolimus cream 1% or vehicle until clearance for up to 4 weeks. Follow-up took place 4 and 8 weeks after treatment.

RESULTS:

Patients treated with pimecrolimus had an average POD Severity Index score of 2.6 compared with 3.5 for patients treated with vehicle. Both groups had baseline scores of 5.2. The between-group difference was 0.9 (95% confidence level 0.4, 1.4, P = .0011). Patients with history of topical corticosteroids benefited most. Pimecrolimus-treated patients reported greater improvement in quality of life. There were no group differences regarding safety.

LIMITATIONS:

Pimecrolimus vehicle is not a true placebo.

CONCLUSIONS:

Pimecrolimus rapidly improves clinical symptoms and quality of life of patients with POD, being most effective in corticosteroid-induced POD.

• Authors: Thomas Schwarz, Inga Kreiselmaier, Thomas Bieber, Diamant Thaci, Jan C Simon, Michael Meurer, Thomas Werfel, Torsten Zuberbier, Thomas A Luger, Andreas Wollenberg, Matthias Bräutigam
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 59 Issue 1 Pg. 34-40 (Jul 2008) ISSN: 1097-6787 [Electronic] United States
• PMID: 18462835 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenal Cortex Hormones
• Anti-Inflammatory Agents, Non-Steroidal
• Dermatologic Agents
• Ointments
• Pharmaceutical Vehicles
• pimecrolimus
• Tacrolimus

Topics

• Administration, Cutaneous
• Adrenal Cortex Hormones (adverse effects)
• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
• Dermatitis, Perioral (chemically induced, drug therapy)
• Dermatologic Agents (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Ointments
• Pharmaceutical Vehicles
• Quality of Life
• Tacrolimus (administration & dosage, analogs & derivatives)
• Treatment Outcome