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

• 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

• Lesion Response [Week12]: Percent of lesions treated at Baseline, in complete response at Week 12
• Pain Score [Baseline (during procedure), assessed after procedure]: Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Lesion Response (Primary), Mean, percentage of lesions complete response: Metvix and Daylight 89.2 +/- 15.0; Metvix and Lamp 92.8 +/- 14.1 (p 0.0345)
• Pain Score (Primary), Mean, units on a scale: Metvix and Daylight 0.8 +/- 1.2; Metvix and Lamp 5.7 +/- 2.3 (p <0.001)

Adverse events

Time frame: From baseline to study end.

Serious adverse events by term

Other adverse events by term

• Stephen Shumack, Principal investigator, St George Dermatology and skin Cancer Center