title: Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes.
abstract: BACKGROUND
  Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis.
  
  
  OBJECTIVE
  Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance.
  
  
  METHODS
  Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded.
  
  
  RESULTS
  Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline.
  
  
  CONCLUSIONS
  Clinical trial population findings may not be generalizable to clinical practice.
  
  
  CONCLUSIONS
  Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.
authors.affiliation: German Center for Health Services Research in Dermatology, University Medical Center, Hamburg, Germany. Electronic address: m.augustin@uke.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Augustin
authors.affiliation: Dermatology Associates of Rochester, Rochester, New York; Department of Dermatology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors.forename: John H
authors.initials: JH
authors.lastname: Tu
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Kim Mark
authors.initials: KM
authors.lastname: Knudsen
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Sandra
authors.initials: S
authors.lastname: Erntoft
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Larsson
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: C William
authors.initials: CW
authors.lastname: Hanke
mesh_terms: D000287:Administration, Topical; D004224:Diterpenes / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D017060:Patient Satisfaction; D014677:Pharmaceutical Vehicles; D011788:Quality of Life; D012646:Self Administration; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: C486592:3-ingenyl angelate; D004224:Diterpenes; D005782:Gels; D014677:Pharmaceutical Vehicles
keywords: Skindex-16; Treatment Satisfaction Questionnaire for Medication; actinic keratosis; clearance; ingenol mebutate; quality of life