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NCT Number: NCT01475071

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).

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigational site, Phillip, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metvix and natural daylight PDT

Drug

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.

Metvix and conventional PDT

Drug

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 outcomes

  1. Lesion Response

    Time frame: Week12

    Percent of lesions treated at Baseline, in complete response at Week 12

  2. Pain Score

    Time frame: Baseline (during procedure), assessed after procedure

    Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 21, 2011
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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