title: Quality of life and side effects in patients with actinic keratosis treated with ingenol mebutate: a pilot study.
abstract: BACKGROUND
  Actinic keratosis (AK) lesions are in situ squamous cell carcinoma. These lesions have a low risk of progressing to invasive disease but significant impact on patients' quality of life (QoL). The aim of this study was to assess QoL and side effects in patients with AK receiving treatment with ingenol mebutate.
  
  
  METHODS
  This was a prospective, non-randomized pilot study carried out in Spain. The target population was adults with a clinical diagnosis of AK affecting any part of the body. Outcomes were assessed on the basis of a QoL questionnaire (Skindex-29), local skin response, the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), and clinical response.
  
  
  RESULTS
  A total of 19 patients were studied. Most of the participants were men (89.5%) and mean age was 76.2 years. After treatment with ingenol mebutate, significant improvement was observed in the Skindex-29 subscales relating to symptom severity (P=.041), the patients' emotional state (P=.026), and in the overall score (P=.014). Erythema, crusting, and flaking or scaling were the local skin responses with highest median score (2.0 in all 3 cases). Imiquimod 5% and ingenol mebutate achieved higher median scores for effectiveness and global satisfaction than any other previous treatments (as measured by TSQM 1.4). In the patients' assessment of convenience, ingenol mebutate had a higher median score than previous treatments. Over half of the patients (52.6%) had an improvement of at least 75% at month 3.
  
  
  CONCLUSIONS
  QoL in patients with AK improves after treatment with ingenol mebutate. The presence of side effects did not affect QoL or patient satisfaction with treatment.
authors.affiliation: Servicio de Dermatología, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Jubert-Esteve
authors.affiliation: Servicio de Dermatología, Hospital Universitario Son Espases, Palma de Mallorca, Spain. Electronic address: lpozoh@gmail.com.
authors.forename: L J
authors.initials: LJ
authors.lastname: Del Pozo-Hernando
authors.affiliation: Servicio de Dermatología, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Izquierdo-Herce
authors.affiliation: Servicio de Dermatología, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Bauzá-Alonso
authors.affiliation: Servicio de Dermatología, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Martín-Santiago
authors.affiliation: Department of Dermatology, University of Sydney, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Jones-Caballero
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004224:Diterpenes / Q000009:adverse effects / Q000627:therapeutic use*; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: C486592:3-ingenyl angelate; D003879:Dermatologic Agents; D004224:Diterpenes
keywords: Actinic keratosis; Efectos secundarios; Ingenol mebutate; Ingenol mebutato; Queratosis actínica; Side effects; Skindex-29; TSMQ 1.4