Trial record 7 of 43 for:    Open Studies | "Keratosis, Actinic"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Galderma
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01821391
First received: March 27, 2013
Last updated: August 29, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    percent of lesions treated at baseline in complete response at week 12


Secondary Outcome Measures:
  • pain score [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    subject self assessment of pain on a scale from 0 to 10.


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821391

Contacts
Contact: Cyril Moulin, Dr +33492383014 cyril.moulin@galderma.com

Locations
France
Investigative site Not yet recruiting
Montpellier, France
Investigational site Recruiting
Nantes, France
Investigational site Not yet recruiting
Nice, France
Investigational site Not yet recruiting
Paris, France
Investigative site Recruiting
Rennes, France
Germany
Investigational site Recruiting
Aachen, Germany
Investigational site Not yet recruiting
Berlin, Germany
Investigational site Not yet recruiting
Muenster, Germany
Investigational site Recruiting
Recklinghausen, Germany
Netherlands
Investigational site Not yet recruiting
Assen, Netherlands
Investigational site Not yet recruiting
Maastricht, Netherlands
Investigational site Not yet recruiting
Nijmegen, Netherlands
Spain
Investigational site Recruiting
Huesca, Spain
Investigational site Not yet recruiting
Madrid, Spain
Investigative site Recruiting
Pamplona, Spain
Investigational site Not yet recruiting
Valencia, Spain
Sweden
Investigational site Not yet recruiting
Karlskoga, Sweden
Investigational site Not yet recruiting
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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01821391     History of Changes
Other Study ID Numbers: RD.03.SPR.29112
Study First Received: March 27, 2013
Last Updated: August 29, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency

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
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014