Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin

Study Overview
=================
Brief Summary
-----------------
Skin photoaging or skin photodamage are terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources. The visible effects of skin photodamage are fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia). More and more people are presenting to doctors with concerns about skin photodamage and the demand for corrective procedures is increasing. Metvix® photodynamic therapy (Metvix® PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom [UK] and Spain) and in Australia, for the treatment of benign forms of skin cancer (e.g. actinic keratosis). The aim of the study is to assess whether Metvix® PDT will be effective in correcting the effects related to photodamage and whether it will be well tolerated.

Detailed Description
-----------------
Different application times of the study treatment are being investigated.

Official Title
-----------------
Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin

Conditions
-----------------
Photoaged Skin

Intervention / Treatment
-----------------
* Procedure: Metvix PDT
* Procedure: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects older than 30 years of age. Subjects with a photodamage grade of at least 4 on the Griffiths photonumeric scale (symmetrical photodamage on the two target areas) Subjects with mottled hyper-pigmentation on the face Subjects willing and capable of cooperating to the extent and degree required by the protocol Subjects must read the Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedures. Exclusion Criteria: Subjects who are at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix® Subjects with suspected porphyria Subjects with specific wash-out period for interfering treatments Subjects requiring concurrent treatment that would interfere with study objectives and/or evaluations

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Metvix PDT<br>* Metvix PDT<br>|
| Placebo Comparator: 2<br> | Procedure: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety parameters (e.g.: severity of photodamage, severity of fine lines, erythema, etc.) |  | every four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDT, Photoaging, Galderma