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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 1, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • Percent change from baseline in total number of treated mild lesions per side at week 12. [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]

    At baseline, mild lesions will be mapped on each side.

    At week 12 each mild lesion response will be assessed per side as:

    • Complete response (Complete disappearance of the lesion, visually and by palpation)
    • Non-complete response (Non-complete disappearance of the lesion)

    At week 12, the percent change from baseline in number of treated mild lesions per side will be calculated.


  • Subject assessment of maximal pain per side at baseline [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    Subject assessment of maximal pain on a scale from 0 (no pain ) to 10 (extreme pain) per side at baseline


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
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
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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01475071     History of Changes
Other Study ID Numbers: RD.03.SPR.29102
Study First Received: October 27, 2011
Last Updated: March 1, 2013
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
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013