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

Galderma

Status and phase: Completed; Phase 2

Conditions: Photoaged Skin

Treatments: Drug: Metvix Vehicle Group; Drug: Metvix Cream 160 mg/g

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437320

2006-004237-15 (EudraCT Number)

RD.03.SPR.29057

Details and patient eligibility

About

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.

Full description

Different application times of the study treatment were being investigated.

Enrollment: 32 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants older than 30 years of age.
• Participants with a photodamage grade of at least 4 on the Griffiths photonumeric scale (symmetrical photodamage on the two target areas)
• Participants with mottled hyper-pigmentation on the face
• Participants willing and capable of cooperating to the extent and degree required by the protocol
• Participants must read the Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedures.

Exclusion criteria

• Participants who were at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix
• Participants with suspected porphyria
• Participants with specific wash-out period for interfering treatments
• Participants requiring concurrent treatment that would interfere with study objectives and/or evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 3 patient groups

Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group)

Experimental group

Description:

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.

Treatment:

Drug: Metvix Cream 160 mg/g

Drug: Metvix Vehicle Group

Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group)

Experimental group

Description:

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.

Treatment:

Drug: Metvix Cream 160 mg/g

Drug: Metvix Vehicle Group

Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group)

Experimental group

Description:

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.

Treatment:

Drug: Metvix Cream 160 mg/g

Drug: Metvix Vehicle Group