J-P Lacour1, C Ulrich2, Y Gilaberte3, V Von Felbert4, N Basset-Seguin5, B Dreno6, C Girard7, P Redondo8, C Serra-Guillen9, I Synnerstad10, M Tarstedt11, A Tsianakas12, A W Venema13, N Kelleners-Smeets14, H Adamski15, B Perez-Garcia16, M J Gerritsen17, S Leclerc18, N Kerrouche18, R-M Szeimies19. 1. Department of Dermatology, Hôpital Archet2, University Hospital of Nice, Nice, France. 2. Charité Campus Mitte, Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie Hautturmorcentrum der Charité (HTCC), Berlin, Germany. 3. Hospital San Jorge, Huesca, Spain. 4. Department of Dermatology, University Hospital, RWTH Aachen University, Aachen, Germany. 5. Saint-Louis Hospital, Paris, France. 6. CHU Hotel Dieu, Nantes Cedex 1, France. 7. Department of Dermatology, Hospital Saint Eloi, Montpellier, France. 8. Department of Dermatology, University Clinic of Navarra, Pamplona, Spain. 9. Instituto Valenciano de Oncologia, Valencia, Spain. 10. Hudmottagningen, Norrköping, Sweden. 11. Department of Dermatology, Karlskoga Hospital, Karlskoga, Sweden. 12. Department of Dermatology, University Hospital of Münster, Münster, Germany. 13. Wilhelmina Ziekenhuis Assen, Assen, The Netherlands. 14. Dermatology Department, Maastricht University Medical Centre, Maastricht, The Netherlands. 15. Dermatology Department, Pontchaillou Hospital, Rennes, France. 16. Hospital Ramón y Cajal, Servicio de Dermatología, Carretera de Colmenar Viejo, Madrid, Spain. 17. Radboud University Medical Center, Nijmegen, The Netherlands. 18. Galderma R&D, Sophia Antipolis, France. 19. Klinik für Dermatologie und Allergologie, Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus, Recklinghausen, Germany.
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. OBJECTIVES: 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. CONCLUSION: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.
RCT Entities:
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. OBJECTIVES: 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. CONCLUSION: 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: Ethan P M LaRochelle; Michael Shane Chapman; Edward V Maytin; Tayyaba Hasan; Brian W Pogue Journal: Photochem Photobiol Date: 2019-10-21 Impact factor: 3.421
Authors: Sigrid Karrer; Rolf-Markus Szeimies; Wolfgang G Philipp-Dormston; Peter A Gerber; Welf Prager; Elisabeth Datz; Florian Zeman; Karolina Müller; Michael Koller Journal: Acta Derm Venereol Date: 2021-01-04 Impact factor: 3.875