A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis - 24/04/13
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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AE, CL, DLQI, POD, PODSI, VAS
Plan
Sponsored by Novartis Pharma GmbH, Nuremberg, Germany. |
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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. |
Vol 59 - N° 1
P. 34-40 - juillet 2008 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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