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

October 27, 2011
March 1, 2013
March 2012
November 2012   (final data collection date for primary outcome measure)
  • 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
Percent change from baseline in number of mild lesions per side at month 3. [ Time Frame: Baseline and month 3 ] [ Designated as safety issue: No ]

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

At month 3 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 month 3, the percent change from baseline in number of mild lesions per side will be calculated.

Complete list of historical versions of study NCT01475071 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Actinic Keratoses
  • 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.
  • 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.
  • Experimental: Metvix and daylight
    Intervention: Drug: Metvix and natural daylight PDT
  • Active Comparator: Metvix and lamp
    Intervention: Drug: Metvix and conventional PDT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01475071
RD.03.SPR.29102
No
Galderma
Galderma
Not Provided
Principal Investigator: Stephen Shumack St George Dermatology and skin Cancer Center
Galderma
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP