title: 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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Dermatology, University of Kiel, Kiel, Germany. tschwarz@dermatology.uni-kiel.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Schwarz
authors.forename: Inga
authors.initials: I
authors.lastname: Kreiselmaier
authors.forename: Thomas
authors.initials: T
authors.lastname: Bieber
authors.forename: Diamant
authors.initials: D
authors.lastname: Thaci
authors.forename: Jan C
authors.initials: JC
authors.lastname: Simon
authors.forename: Michael
authors.initials: M
authors.lastname: Meurer
authors.forename: Thomas
authors.initials: T
authors.lastname: Werfel
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Luger
authors.forename: Andreas
authors.initials: A
authors.lastname: Wollenberg
authors.forename: Matthias
authors.initials: M
authors.lastname: Bräutigam
mesh_terms: D000279:Administration, Cutaneous; D000305:Adrenal Cortex Hormones / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D019557:Dermatitis, Perioral / Q000139:chemically induced / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D014677:Pharmaceutical Vehicles; D011788:Quality of Life; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D009824:Ointments; D014677:Pharmaceutical Vehicles; C117268:pimecrolimus; D016559:Tacrolimus