title: Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies.
abstract: BACKGROUND
  Imiquimod is an immune response modifier that is a Toll-like receptor 7 agonist that induces interferon and other cytokines through the innate immune system and stimulates cell-mediated immunity through T cells. Imiquimod has been shown to be efficacious as a topical treatment for basal cell carcinoma (BCC).
  
  
  OBJECTIVE
  We sought to evaluate the efficacy and safety of imiquimod 5% cream compared with vehicle for treating superficial BCC (sBCC).
  
  
  METHODS
  Two identical studies were conducted. Subjects with one sBCC were dosed with imiquimod or vehicle cream once daily 5 or 7x/week for 6 weeks in these 2 randomized, double-blind, vehicle-controlled Phase III studies. The lesion site was clinically examined 12 weeks posttreatment and then excised for histological evaluation.
  
  
  RESULTS
  Data from both studies were pooled. Composite clearance rates (combined clinical and histological assessments) for the 5 and 7x/week imiquimod groups were 75% and 73%, respectively. Histological clearance rates for the 5 and 7x/week imiquimod groups were 82% and 79%, respectively. Increasing severity of erythema, erosion, and scabbing/crusting was associated with higher clearance rates.
  
  
  CONCLUSIONS
  Imiquimod appears to be safe and effective for the treatment of sBCC when compared with vehicle cream. The difference in clearance rates between the two imiquimod dosing groups was not significant. The 5x/week regimen is recommended.
authors.affiliation: Solano Dermatology Associates, Vallejo, CA 94589, USA. jgeisse@solderm.com
authors.forename: John
authors.initials: J
authors.lastname: Geisse
authors.forename: Ivor
authors.initials: I
authors.lastname: Caro
authors.forename: Jane
authors.initials: J
authors.lastname: Lindholm
authors.forename: Loren
authors.initials: L
authors.lastname: Golitz
authors.forename: Patti
authors.initials: P
authors.lastname: Stampone
authors.forename: Mary
authors.initials: M
authors.lastname: Owens
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D002280:Basal Cell Carcinoma / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077271:Imiquimod; D007369:Interferon Inducers / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009824:Ointments; D014677:Pharmaceutical Vehicles; D012878:Skin Neoplasms / Q000188:drug therapy*
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D007369:Interferon Inducers; D009824:Ointments; D014677:Pharmaceutical Vehicles; D000077271:Imiquimod