Title
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
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
Phase
Phase 3Lead Sponsor
GaldermaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Actinic KeratosesIntervention/Treatment
methyl aminolevulinate ...Study Participants
131This 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.
Metvix natural daylight photodynamic therapy
Metvix conventional photodynamic therapy
Metvix placebo conventional photodynamic therapy
Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
Inclusion Criteria: Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs Exclusion Criteria: Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas Subject with pigmented AK on the treated areas Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons Subject with porphyria,
| Event Type | Organ System | Event Term | NDL-PDT | c-PDT | Placebo c-PDT | Unspecific Treated Side |
|---|
The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I).
