title: Long-term sustained lesion clearance from Lmax with imiquimod 3.75%, a new field-directed treatment for actinic keratosis.
abstract: BACKGROUND
  In patients with actinic keratosis (AK), subclinical and clinical lesions coexist across large areas of sun-exposed skin. The long-term efficacy of AK treatments depends on their ability to eradicate both types of lesions across the entire field.
  
  
  OBJECTIVE
  To assess the long-term efficacy of imiquimod 3.75% using the reduction in lesions from Lmax (maximum lesion count during treatment), which assesses the ability to clear subclinical and clinical lesions.
  
  
  METHODS
  Patients with 5-20 AK lesions on the full face or balding scalp from two 14-week, randomized, vehicle-controlled, double-blind studies of imiquimod 3.75% (daily for two 2-week treatment cycles separated by a 2-week treatment-free period) were eligible to enter a 12-month follow-up study if they had no AK lesions at Week 14. Lesion reduction from Lmax was calculated at 6 and 12 months during follow-up.
  
  
  RESULTS
  The 42 patients in this long-term study had a median of nine baseline lesions and a median Lmax of 22 lesions. At 6 and 12 months of follow-up, the median absolute reduction in AK lesions from Lmax with imiquimod 3.75% was 21 and 19, respectively. The median percentage reduction in lesions from Lmax to 6 and 12 months was 100% and 97.2%, respectively.
  
  
  CONCLUSIONS
  The ability of imiquimod 3.75% to eliminate clinical and subclinical lesions across an entire sun-exposed field translates into sustained long-term efficacy. Imiquimod 3.75% may therefore represent a first-choice treatment for patients with AK.
authors.affiliation: Department of Dermatology, Monklands Hospital, Airdrie, Lanarkshire, UK.
authors.forename: G
authors.initials: G
authors.lastname: Gupta
authors.affiliation: Department of Dermatology, Charité - University Medical Centre Berlin, Berlin, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Stockfleth
authors.affiliation: Department of Dermatology, Catholic University of Rome, Rome, Italy.
authors.forename: K
authors.initials: K
authors.lastname: Peris
authors.affiliation: Service de Dermatologie Allergologie, Hôpital Cochin, Paris, France.|Université Paris 5 Descartes, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Aractingi
authors.affiliation: Department of Dermatology, Institut Universitari Quiron Dexeus, Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Alomar
authors.affiliation: Meda Pharma GmbH & Co. KG, Bad Homburg, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Dakovic
authors.affiliation: Dermatological Practice Centre, Wuppertal, Germany.|Faculty of Health, University Witten-Herdecke, Witten, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Dirschka
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000493:pharmacokinetics; D000287:Administration, Topical; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage / Q000493:pharmacokinetics*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D055623:Keratosis, Actinic / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D008297:Male; D012535:Scalp; D012720:Severity of Illness Index; D012867:Skin / Q000378:metabolism / Q000473:pathology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D003692:Delayed-Action Preparations; D000077271:Imiquimod