Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses (COMET2)

February 16, 2021 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Investigative Site
      • Nantes, France
        • Investigational Site
      • Nice, France
        • Investigational Site
      • Paris, France
        • Investigational Site
      • Rennes, France
        • Investigative Site
  • Germany
      • Aachen, Germany
        • Investigational Site
      • Berlin, Germany
        • Investigational Site
      • Muenster, Germany
        • Investigational Site
      • Recklinghausen, Germany
        • Investigational Site
  • Netherlands
      • Assen, Netherlands
        • Investigational Site
      • Maastricht, Netherlands
        • Investigational Site
      • Nijmegen, Netherlands
        • Investigational Site
  • Spain
      • Huesca, Spain
        • Investigational Site
      • Madrid, Spain
        • Investigational Site
      • Pamplona, Spain
        • Investigative Site
      • Valencia, Spain
        • Investigational Site
  • Sweden
      • Karlskoga, Sweden
        • Investigational Site
      • Norrköping, Sweden
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NDL-PDT/c-PDT
Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
Drug: NDL-PDT
Metvix natural daylight photodynamic therapy
Other Names:
  • Metvix NDL-PDT
Drug: c-PDT
Metvix conventional photodynamic therapy
Other Names:
  • Metvix c-PDT
Experimental: NDL-PDT/placebo c-PDT
Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
Drug: NDL-PDT
Metvix natural daylight photodynamic therapy
Other Names:
  • Metvix NDL-PDT
Drug: placebo c-PDT
Metvix placebo conventional photodynamic therapy
Other Names:
  • Metvix placebo c-PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Nicole Basset Seguin, PhD, MD, Hopital Saint Louis France
  • Principal Investigator: Bibiana Perez Garcia, MD, Hospital Ramón y Cajal Spain
  • Principal Investigator: Rianne Gerritsen, PhD, MD, Radboud University, Nijmegen Medical Center The Netherlands
  • Principal Investigator: Rolf-Markus Sziemies, PhD, MD, Klinik fur Dermatologie und Allergologie Germany
  • Principal Investigator: Ingrid Synnerstad, PhD, MD, Hudmottagningen Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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