Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

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,