title: A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body.
abstract: BACKGROUND
  Actinic keratoses (AKs) are precursors to invasive squamous cell carcinoma and can progress if untreated. Limited data support the use of ingenol mebutate to treat AKs on more than one area of the body simultaneously.
  
  
  OBJECTIVE
  To investigate safety, efficacy and treatment satisfaction when treating separate areas simultaneously or sequentially with different concentrations of ingenol mebutate gel.
  
  
  METHODS
  In this phase IIIb study (NCT01787383), patients with clinically visible, non-hyperkeratotic AKs on two separate treatment areas (face/scalp and trunk/extremities) were randomized to simultaneous or sequential treatment with ingenol mebutate gel (0.015% and 0.05%). Endpoints included composite local skin response (LSR) score 3 days after first application, complete AK clearance and percentage reduction in AKs at week 8.
  
  
  RESULTS
  There were no statistically significant differences between simultaneous (n = 101) and sequential (n = 98) groups in composite LSR score (10.4 vs. 9.7), complete clearance (52.7% vs. 46.9%) or percentage reduction in AKs (83.4% vs. 79.1%). Mean composite LSR scores on face/scalp and trunk/extremities were similar for both groups. Adverse event (AE) incidence was comparable between groups, the most common treatment-related AEs being pruritus and pain at the application site.
  
  
  CONCLUSIONS
  Treating AKs with ingenol mebutate simultaneously or sequentially gave similar results in terms of tolerability (LSR score, AEs) and efficacy (complete clearance). Therefore, the physician and patient can select the most convenient treatment regimen, with confidence in achieving a similar outcome.
authors: Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy.
authors: G
authors: G
authors: Pellacani
authors: Department of Dermatology, Catholic University of Rome, Rome, Italy.
authors: K
authors: K
authors: Peris
authors: Department of Dermatology, Instituto Valenciano de Oncología, Valencia, Spain.
authors: C
authors: C
authors: Guillen
authors: LEO Pharma A/S, Ballerup, Denmark.
authors: F
authors: F
authors: Clonier
authors: LEO Pharma A/S, Ballerup, Denmark.
authors: T
authors: T
authors: Larsson
authors: LEO Pharma A/S, Ballerup, Denmark.
authors: R
authors: R
authors: Venkata
authors: Melanoma Unit, Dermatology Department, Hospital Clinic of Barcelona, University of Barcelona & CIBERER, Instituto de Slud Carlos III, Barcelona, Spain.
authors: S
authors: S
authors: Puig
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004224:Diterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D005121:Extremities; D005148:Facial Dermatoses / Q000188:drug therapy; D005260:Female; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D017060:Patient Satisfaction; D012536:Scalp Dermatoses / Q000188:drug therapy; D060726:Torso; D016896:Treatment Outcome
chemical_list: C486592:3-ingenyl angelate; D000970:Antineoplastic Agents; D004224:Diterpenes; D005782:Gels