Actinic Keratoses Treatment With Metvix® in Combination With Light

Study Overview
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Brief Summary
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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 in subjects with mild actinic keratoses (intra-individual comparison)

Official Title
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Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Metvix®
* Procedure: Photodynamic Therapy Blue light
* Procedure: Photodynamic Therapy Daylight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female above 18 years; Subject with clinical diagnosis of mild Actinic Keratosis (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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daylight<br>Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline | Drug: Metvix®<br> <br> Procedure: Photodynamic Therapy Daylight<br>* Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug<br>|
| Active Comparator: Conventional treatment<br>Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline | Drug: Metvix®<br> <br> Procedure: Photodynamic Therapy Blue light<br>* Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 | The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assesment | Pain assesment with a VAS Pain scale Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). | at inclusion (after treatment) | 
| Lesions Disappearance Rate at 1 Months From Baseline. | The number of lesions is assessed at baseline (before treatment) and 1 month later. The difference in lesions is recorded for each patient. The rate is the quotient:  difference in lesions between baseline and at 1 month /nubmer of lesions at baseline | 0(baseline),1 month | 
| Lesions Disappearance Rate at 6 Months From Baseline. | The number of lesions is assessed at baseline (before treatment) and 6 month later. The difference in lesions is recorded for each patient. The rate is the quotient:  difference in lesions between baseline and at 6 month /nubmer of lesions at baseline | 0(baseline), 6 month |