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 (COMET2)

NCT01821391 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Galderma R&D
Phase	Phase 3
Status	COMPLETED
Enrolment	131
Start date	2013-07
Completion	2014-03

Conditions

• Actinic Keratoses

Interventions

• NDL-PDT
• c-PDT
• placebo c-PDT

Primary outcomes

• Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 — Baseline, Week 12
  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).

Countries

France, Germany, Netherlands, Spain, Sweden