Conditions: Actinic Keratoses
Keywords: actinic keratoses photodynamic therapy natural daylight
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 131
Healthy volunteers: no

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:

Arms:
arm 1: Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy arm 2: Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy

Interventions: intervention 1: NDL-PDT intervention 2: c-PDT intervention 3: placebo c-PDT
Intervention descriptions: intervention 1: Metvix natural daylight photodynamic therapy intervention 2: Metvix conventional photodynamic therapy intervention 3: Metvix placebo conventional photodynamic therapy

Protocol document: