NCT01821391

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	NDL-PDT	Metvix natural daylight photodynamic therapy
DRUG	c-PDT	Metvix conventional photodynamic therapy
DRUG	placebo c-PDT	Metvix placebo conventional photodynamic therapy

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2013-04-01
• Last updated: 2021-02-18
• Results posted: 2020-12-10

Locations

18 sites across 5 countries: France, Germany, Netherlands, Spain, Sweden