Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin|
- Efficacy and safety parameters (e.g.: severity of photodamage, severity of fine lines, erythema, etc.) [ Time Frame: every four weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Procedure: Metvix PDT
|Placebo Comparator: 2||
Different application times of the study treatment are being investigated.