Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses (CoMet)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01475071
First received: October 27, 2011
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Condition Intervention Phase
Actinic Keratoses
Drug: Metvix and natural daylight PDT
Drug: Metvix and conventional PDT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Lesion Response [ Time Frame: Week12 ] [ Designated as safety issue: No ]
    Percent of lesions treated at Baseline, in complete response at Week 12

  • Pain Score [ Time Frame: Baseline (during procedure), assessed after procedure ] [ Designated as safety issue: Yes ]
    Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)


Enrollment: 100
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metvix and daylight Drug: Metvix and natural daylight PDT
Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
Active Comparator: Metvix and lamp Drug: Metvix and conventional PDT
Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female above 18 years;
  2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

  1. Subject with clinical diagnosis of at least one severe AK on TAs
  2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
  3. Subject with pigmented AK on the TAs
  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: NCT01475071

Locations
Australia, Australian Capital Territory
Galderma Investigational site
Phillip, Australian Capital Territory, Australia
Australia, New South Wales
Galderma Investigational Site
Kogarah, New South Wales, Australia
Galderma Investigational site
Sydney, New South Wales, Australia
Galderma Investigational site
Westmead, New South Wales, Australia
Australia, Queensland
Galderma Investigational site
Woolloongabba, Queensland, Australia
Australia, Victoria
Galderma Investigational site
Carlton, Victoria, Australia
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Stephen Shumack St George Dermatology and skin Cancer Center
  More Information

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01475071     History of Changes
Other Study ID Numbers: RD.03.SPR.29102 
Study First Received: October 27, 2011
Results First Received: August 29, 2013
Last Updated: March 17, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on August 23, 2016