Conditions: Photoaged Skin
Keywords: PDT Photoaging Galderma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
Skin photoaging or skin photodamage were 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 were 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 were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was 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 (example, actinic keratosis).

The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.

Detailed description:
Different application times of the study treatment were being investigated.

Arms:
arm 1: Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \[using a large-field light emitting diode (LED) light source: Aktilite 128 lamp\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\^2. The total study duration was 20 weeks. arm 2: Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks. arm 3: Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks.

Interventions: intervention 1: Metvix Cream 160 mg/g intervention 2: Metvix Vehicle Group
Intervention descriptions: intervention 1: Participants were treated with topical administration of Metvix cream. intervention 2: Participants were treated with topical administration of Metvix Vehicle cream.

Protocol document: