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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative site, Montpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

NDL-PDT

Drug

Metvix natural daylight photodynamic therapy

Other names: Metvix NDL-PDT

c-PDT

Drug

Metvix conventional photodynamic therapy

Other names: Metvix c-PDT

placebo c-PDT

Drug

Metvix placebo conventional photodynamic therapy

Other names: Metvix placebo c-PDT

Primary outcomes

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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: COMET2

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 1, 2013
Registry last updated: Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed