title: Efficacy and safety of follow-up field treatment of actinic keratosis with ingenol mebutate 0·015% gel: a randomized, controlled 12-month study.
abstract: BACKGROUND
  Ingenol mebutate (IngMeb) is a novel patient-applied topical field therapy for actinic keratosis.
  
  
  OBJECTIVE
  To demonstrate the efficacy and safety of follow-up IngMeb field treatment of actinic keratoses (AKs) present at 8 weeks after initial treatment or emerging in a previously cleared field.
  
  
  METHODS
  In this phase III, randomized, double-blind study in patients with 4-8 clinically visible AKs within a contiguous 25-cm(2) treatment area on the face or scalp, all patients were treated initially with IngMeb 0·015% gel for three consecutive days. If lesions were present in the field at 8 weeks, or emerged at weeks 26 or 44, patients were randomized (2 : 1) to follow-up IngMeb or vehicle gel for three consecutive days. The main outcome was complete clearance rates of AKs 8 weeks after randomization.
  
  
  RESULTS
  Of 450 patients who received initial treatment with IngMeb, 61·6% demonstrated complete clearance at 8 weeks. Patients with AKs present at 8 weeks or emerging at weeks 26 or 44 were randomized to IngMeb (n = 134) or vehicle (n = 69). IngMeb achieved a higher complete clearance rate than vehicle 8 weeks after randomization in AKs present at 8 weeks (46·7% vs. 18·4%; P < 0·01) and in emergent AKs (59·5% vs. 25·0%; P = 0·01). Based on those who completed 12 months of follow-up (n = 340), the overall 12-month clearance rate was estimated at 50·0%. Follow-up IngMeb treatment was well tolerated.
  
  
  CONCLUSIONS
  This study demonstrated the long-term benefit of IngMeb 0·015% gel for initial and follow-up therapy of AKs.
authors.affiliation: Department of Dermatology, Division of Dermatooncology, University Hospital Tübingen, Tübingen, 72076, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Garbe
authors.affiliation: Hôpital Saint-Louis, Paris, France.
authors.forename: N
authors.initials: N
authors.lastname: Basset-Seguin
authors.affiliation: Laval University, Quebec City, QC, Canada.|Center for Research in Dermatology, Quebec City, QC, Canada.
authors.forename: Y
authors.initials: Y
authors.lastname: Poulin
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: T
authors.initials: T
authors.lastname: Larsson
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: M L
authors.initials: ML
authors.lastname: Østerdal
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: R
authors.initials: R
authors.lastname: Venkata
authors.affiliation: Department of Dermatology, Manchester Royal Infirmary and Manchester Academics Health Science Centre, Manchester University, Manchester, U.K.
authors.forename: J T
authors.initials: JT
authors.lastname: Lear
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004224:Diterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C486592:3-ingenyl angelate; D003879:Dermatologic Agents; D004224:Diterpenes; D005782:Gels