Spots Global Cancer Trial Database for Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
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Trial Identification
Brief Title: Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Official Title: Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis
Study ID: NCT01821391
Conditions
Study Description
Brief Summary: This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study. The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigative site, Montpellier, , France
Investigational site, Nantes, , France
Investigational site, Nice, , France
Investigational site, Paris, , France
Investigative site, Rennes, , France
Investigational site, Aachen, , Germany
Investigational site, Berlin, , Germany
Investigational site, Muenster, , Germany
Investigational site, Recklinghausen, , Germany
Investigational site, Assen, , Netherlands
Investigational site, Maastricht, , Netherlands
Investigational site, Nijmegen, , Netherlands
Investigational site, Huesca, , Spain
Investigational site, Madrid, , Spain
Investigative site, Pamplona, , Spain
Investigational site, Valencia, , Spain
Investigational site, Karlskoga, , Sweden
Investigational site, Norrköping, , Sweden
Contact Details
Name: Nicole Basset Seguin, PhD, MD
Affiliation: Hopital Saint Louis France
Role: PRINCIPAL_INVESTIGATOR
Name: Bibiana Perez Garcia, MD
Affiliation: Hospital Ramón y Cajal Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Rianne Gerritsen, PhD, MD
Affiliation: Radboud University, Nijmegen Medical Center The Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: Rolf-Markus Sziemies, PhD, MD
Affiliation: Klinik fur Dermatologie und Allergologie Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Ingrid Synnerstad, PhD, MD
Affiliation: Hudmottagningen Sweden
Role: PRINCIPAL_INVESTIGATOR
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