title: Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis.
abstract: BACKGROUND
  Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production.
  
  
  OBJECTIVE
  We sought to compare the efficacy and safety of twice-daily pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis.
  
  
  METHODS
  This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations.
  
  
  RESULTS
  In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [-0.195, 0.961]). Per protocol analysis (n = 41 pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (pimecrolimus = 26%; vehicle = 12%).
  
  
  CONCLUSIONS
  Generalizability is limited by the elderly male study population.
  
  
  CONCLUSIONS
  This study suggests that pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.
authors.affiliation: Minneapolis Department of Veterans Affairs Medical Center, University of Minnesota, Minneapolis MN 55417, USA. Erin.Warshaw@med.va.gov
authors.forename: Erin M
authors.initials: EM
authors.lastname: Warshaw
authors.forename: Ross Jon
authors.initials: RJ
authors.lastname: Wohlhuter
authors.forename: An
authors.initials: A
authors.lastname: Liu
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Zeller
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Wenner
authors.forename: Sacharitha
authors.initials: S
authors.lastname: Bowers
authors.forename: Julie C
authors.initials: JC
authors.lastname: Schultz
authors.forename: H Irving
authors.initials: HI
authors.lastname: Katz
authors.forename: Calogera L
authors.initials: CL
authors.lastname: McCormick
authors.forename: Anne
authors.initials: A
authors.lastname: Parneix-Spake
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C117268:pimecrolimus; D016559:Tacrolimus