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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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.
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.
Galderma Investigational site
Phillip, Australian Capital Territory, Australia
Galderma Investigational Site
Kogarah, New South Wales, Australia
Galderma Investigational site
Sydney, New South Wales, Australia
Galderma Investigational site
Westmead, New South Wales, Australia
Lesion Response
Percent of lesions treated at Baseline, in complete response at Week 12
Time frame: Week12
Pain Score
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Time frame: Baseline (during procedure), assessed after procedure
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Galderma Investigational site
Woolloongabba, Queensland, Australia
Galderma Investigational site
Carlton, Victoria, Australia