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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01821391
First Posted: April 1, 2013
Last Update Posted: September 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma
  Purpose

This study will be conducted as a multi-centre, randomized, investigator-blind, active and vehicle-controlled, intra-individual study.

The purpose of this study is to confirm that the Metvix NDL-PDT procedure is similar in efficacy and less painful when compared to Metvix c-PDT procedure for the treatment of mild and moderate AKs.

In addition this study will include a Metvix NDL-PDT arm versus Metvix vehicle cream c PDT (Placebo) to assess the sensitivity of the trial.


Condition Intervention Phase
Actinic Keratoses Drug: NDL-PDT Drug: c-PDT Drug: placebo c-PDT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • lesion response [ Time Frame: week 12 ]
    percent of lesions treated at baseline in complete response at week 12


Other Outcome Measures:
  • Pain Score [ Time Frame: Baseline ]
    Subject self assessment of pain on a scale from 0 to 10


Enrollment: 131
Study Start Date: July 2013
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NDL-PDT/c-PDT
Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
Drug: NDL-PDT
Metvix natural daylight photodynamic therapy
Other Name: Metvix NDL-PDT
Drug: c-PDT
Metvix conventional photodynamic therapy
Other Name: 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 Name: Metvix NDL-PDT
Drug: placebo c-PDT
Metvix placebo conventional photodynamic therapy
Other Name: Metvix placebo c-PDT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821391


Locations
France
Investigative site
Montpellier, France
Investigational site
Nantes, France
Investigational site
Nice, France
Investigational site
Paris, France
Investigative site
Rennes, France
Germany
Investigational site
Aachen, Germany
Investigational site
Berlin, Germany
Investigational site
Muenster, Germany
Investigational site
Recklinghausen, Germany
Netherlands
Investigational site
Assen, Netherlands
Investigational site
Maastricht, Netherlands
Investigational site
Nijmegen, Netherlands
Spain
Investigational site
Huesca, Spain
Investigational site
Madrid, Spain
Investigative site
Pamplona, Spain
Investigational site
Valencia, Spain
Sweden
Investigational site
Karlskoga, Sweden
Investigational site
Norrköping, Sweden
Sponsors and Collaborators
Galderma
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
  More Information

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01821391     History of Changes
Other Study ID Numbers: RD.03.SPR.29112
First Submitted: March 27, 2013
First Posted: April 1, 2013
Last Update Posted: September 12, 2014
Last Verified: September 2014

Keywords provided by Galderma:
actinic keratoses
photodynamic therapy
natural daylight

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents