title: Daylight photodynamic therapy with methyl aminolevulinate cream is effective and nearly painless in treating actinic keratoses: a randomised, investigator-blinded, controlled, phase III study throughout Europe.
abstract: BACKGROUND
  Unmet needs exist in actinic keratosis (AK) treatment. Daylight photodynamic therapy (DL-PDT) has shown good efficacy and safety results compared to conventional PDT (c-PDT) in a recent Phase III multi-centre randomised controlled trial in Australia among 100 subjects with AKs.
  
  
  OBJECTIVE
  Demonstrate non-inferior efficacy and superior safety of DL-PDT compared to c-PDT in treating multiple mild and/or moderate facial/scalp AKs.
  
  
  METHODS
  Phase III, 12 week, multi-centre, randomised, investigator-blinded, controlled, intra-individual study conducted at different latitudes in Europe. AKs of adult subjects were treated once with methyl aminolevulinate (MAL) DL-PDT on one side of the face and MAL c-PDT contralaterally. Endpoints for DL-PDT concerned efficacy (non-inferiority regarding complete lesion response at week 12) and safety (superiority regarding subject's assessment of pain after treatment, on an 11-point numeric rating scale). Safety evaluation also included incidence of adverse events. Subject satisfaction was described using a questionnaire at baseline and last visit.
  
  
  RESULTS
  At week 12, the total lesion complete response rate with DL-PDT was similar (non-inferior) to c-PDT (70% vs. 74%, respectively; 95% CI [-9.5; 2.4] in PP analysis, confirmed in ITT analysis). In addition, efficacy of DL-PDT was demonstrated regardless of weather conditions (sunny or cloudy). DL-PDT was nearly painless compared to c-PDT (0.7 vs. 4.4, respectively; P < 0.001), better tolerated and resulted in higher subject satisfaction.
  
  
  CONCLUSIONS
  DL-PDT in comparison with c-PDT was as effective, better tolerated and nearly painless with high patient satisfaction, and may be considered a treatment of choice to meet needs of patients with mild or moderate facial/scalp AKs.
authors.affiliation: Department of Dermatology, Hôpital Archet2, University Hospital of Nice, Nice, France.
authors.forename: J-P
authors.initials: JP
authors.lastname: Lacour
authors.affiliation: Charité Campus Mitte, Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie Hautturmorcentrum der Charité (HTCC), Berlin, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Ulrich
authors.affiliation: Hospital San Jorge, Huesca, Spain.
authors.forename: Y
authors.initials: Y
authors.lastname: Gilaberte
authors.affiliation: Department of Dermatology, University Hospital, RWTH Aachen University, Aachen, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Von Felbert
authors.affiliation: Saint-Louis Hospital, Paris, France.
authors.forename: N
authors.initials: N
authors.lastname: Basset-Seguin
authors.affiliation: CHU Hotel Dieu, Nantes Cedex 1, France.
authors.forename: B
authors.initials: B
authors.lastname: Dreno
authors.affiliation: Department of Dermatology, Hospital Saint Eloi, Montpellier, France.
authors.forename: C
authors.initials: C
authors.lastname: Girard
authors.affiliation: Department of Dermatology, University Clinic of Navarra, Pamplona, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Redondo
authors.affiliation: Instituto Valenciano de Oncologia, Valencia, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Serra-Guillen
authors.affiliation: Hudmottagningen, Norrköping, Sweden.
authors.forename: I
authors.initials: I
authors.lastname: Synnerstad
authors.affiliation: Department of Dermatology, Karlskoga Hospital, Karlskoga, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Tarstedt
authors.affiliation: Department of Dermatology, University Hospital of Münster, Münster, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Tsianakas
authors.affiliation: Wilhelmina Ziekenhuis Assen, Assen, The Netherlands.
authors.forename: A W
authors.initials: AW
authors.lastname: Venema
authors.affiliation: Dermatology Department, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: N
authors.initials: N
authors.lastname: Kelleners-Smeets
authors.affiliation: Dermatology Department, Pontchaillou Hospital, Rennes, France.
authors.forename: H
authors.initials: H
authors.lastname: Adamski
authors.affiliation: Hospital Ramón y Cajal, Servicio de Dermatología, Carretera de Colmenar Viejo, Madrid, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Perez-Garcia
authors.affiliation: Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: M J
authors.initials: MJ
authors.lastname: Gerritsen
authors.affiliation: Galderma R&D, Sophia Antipolis, France.
authors.forename: S
authors.initials: S
authors.lastname: Leclerc
authors.affiliation: Galderma R&D, Sophia Antipolis, France.
authors.forename: N
authors.initials: N
authors.lastname: Kerrouche
authors.affiliation: Klinik für Dermatologie und Allergologie, Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus, Recklinghausen, Germany.
authors.forename: R-M
authors.initials: RM
authors.lastname: Szeimies
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005060:Europe; D005148:Facial Dermatoses / Q000188:drug therapy; D005260:Female; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D017060:Patient Satisfaction; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D012536:Scalp Dermatoses / Q000188:drug therapy; D012720:Severity of Illness Index; D016037:Single-Blind Method; D063465:Skin Cream; D013472:Sunlight / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid