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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 2012

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Metvix and daylight
  • Active Comparator: Metvix and lamp

Clinical Trial Outcome Measures

Primary Measures

  • Lesion Response
    • Time Frame: Week12
    • Percent of lesions treated at Baseline, in complete response at Week 12
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephen Shumack, Principal Investigator, St George Dermatology and skin Cancer Center

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