Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin
|ClinicalTrials.gov Identifier: NCT00437320|
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : January 7, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Photoaged Skin||Procedure: Metvix PDT Procedure: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Procedure: Metvix PDT
|Placebo Comparator: 2||
- Efficacy and safety parameters (e.g.: severity of photodamage, severity of fine lines, erythema, etc.) [ Time Frame: every four weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437320
|University of Manchester-Hope Hospital|
|Manchester, United Kingdom|
|Principal Investigator:||CEM Griffiths, Professor||Manchester Hope Hospital|