A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis - 24/04/13

Doi : 10.1016/j.jaad.2008.03.043

Thomas Schwarz, MD ^a,^⁎ , Inga Kreiselmaier, MD ^a, Thomas Bieber, MD ^b, Diamant Thaci, MD ^c, Jan C. Simon, MD ^d, Michael Meurer, MD ^e, Thomas Werfel, MD ^f, Torsten Zuberbier, MD ^g, Thomas A. Luger, MD ^h, Andreas Wollenberg, MD ⁱ, Matthias Bräutigam, PhD ^j
^a Department of Dermatology at the University of Kiel, Kiel, Germany
^b Department of Dermatology at the University of Bonn, Bonn, Germany
^c Department of Dermatology at the University of Frankfurt, Frankfurt, Germany
^d Department of Dermatology at the University of Leipzig, Leipzig, Germany
^e Department of Dermatology at the University of Dresden, Dresden, Germany
^f Department of Dermatology at the University of Hanover, Hanover, Germany
^g Department of Dermatology at the University of Berlin, Berlin, Germany
^h Department of Dermatology at the University of Münster, Münster, Germany
ⁱ Department of Dermatology at the University of Munich, Munich, Germany
^j Novartis Pharma GmbH, Nuremberg, Germany

Reprint requests: Thomas Schwarz, MD, Department of Dermatology, University of Kiel, Schittenhelmstrasse 7, D-24105 Kiel, Germany.

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.

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Abbreviations used : AE, CL, DLQI, POD, PODSI, VAS

Plan

Methods

Study design

Patients and demographics

Steroid-associated versus steroid-nonassociated POD

Follow-up phase

Adverse events

Discussion

	Sponsored by Novartis Pharma GmbH, Nuremberg, Germany.
	Disclosure: Drs Schwarz, Bieber, Thaci, Simon, Meurer, Werfel, Zuberbier, Luger, and Wollenberg served as a consultants, speakers, and investigators for Novartis Pharma. Dr Bräutigam serves as an employee for Novartis Pharma. Dr Kreiselmaier has no conflicts of interest to declare.