title: Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results.
abstract: BACKGROUND
  Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions.
  
  
  METHODS
  FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle.
  
  
  RESULTS
  Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated.
  
  
  CONCLUSIONS
  Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.
authors: Brian
authors: B
authors: Berman
authors: Gary
authors: G
authors: Goldenberg
authors: C William
authors: CW
authors: Hanke
authors: Stephen K
authors: SK
authors: Tyring
authors: Wm Philip
authors: WP
authors: Werschler
authors: Kim Mark
authors: KM
authors: Knudsen
authors: Joana
authors: J
authors: Goncalves
authors: Thomas
authors: T
authors: Larsson
authors: Torsten
authors: T
authors: Skov
authors: Neil
authors: N
authors: Swanson
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D003131:Combined Modality Therapy; D003452:Cryosurgery / Q000379:methods; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004224:Diterpenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D012535:Scalp; D016896:Treatment Outcome
chemical_list: C486592:3-ingenyl angelate; D003879:Dermatologic Agents; D004224:Diterpenes; D005782:Gels