Back to resultsIntra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses (CoMet)
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Metvix and natural daylight PDT
Metvix and conventional PDT
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses
Eligibility Criteria
Inclusion Criteria:
- Male or female above 18 years;
- 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:
- Subject with clinical diagnosis of at least one severe AK on TAs
- Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
- Subject with pigmented AK on the TAs
Sites / Locations
- Galderma Investigational site
- Galderma Investigational Site
- Galderma Investigational site
- Galderma Investigational site
- Galderma Investigational site
- Galderma Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metvix and daylight
Metvix and lamp
Arm Description
Outcomes
Primary Outcome Measures
Lesion Response
Percent of lesions treated at Baseline, in complete response at Week 12
Pain Score
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01475071
Brief 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
Acronym
CoMet
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metvix and daylight
Arm Type
Experimental
Arm Title
Metvix and lamp
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metvix and natural daylight PDT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metvix and conventional PDT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lesion Response
Description
Percent of lesions treated at Baseline, in complete response at Week 12
Time Frame
Week12
Title
Pain Score
Description
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Time Frame
Baseline (during procedure), assessed after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female above 18 years;
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:
Subject with clinical diagnosis of at least one severe AK on TAs
Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
Subject with pigmented AK on the TAs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Shumack
Organizational Affiliation
St George Dermatology and skin Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galderma Investigational site
City
Phillip
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Galderma Investigational Site
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Galderma Investigational site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Galderma Investigational site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Galderma Investigational site
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Galderma Investigational site
City
Carlton
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
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