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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-18

Study Completion Date

2008-09-01

Brief Summary

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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.

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Detailed Description

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Different application times of the study treatment were being investigated.

Conditions

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Photoaged Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

Metvix Cream 160 mg/g

Intervention Type DRUG

Participants were treated with topical administration of Metvix cream.

Metvix Vehicle Group

Intervention Type DRUG

Participants were treated with topical administration of Metvix Vehicle cream.

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

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.

Group Type EXPERIMENTAL

Metvix Cream 160 mg/g

Intervention Type DRUG

Participants were treated with topical administration of Metvix cream.

Metvix Vehicle Group

Intervention Type DRUG

Participants were treated with topical administration of Metvix Vehicle cream.

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

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.

Group Type EXPERIMENTAL

Metvix Cream 160 mg/g

Intervention Type DRUG

Participants were treated with topical administration of Metvix cream.

Metvix Vehicle Group

Intervention Type DRUG

Participants were treated with topical administration of Metvix Vehicle cream.

Interventions

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Metvix Cream 160 mg/g

Participants were treated with topical administration of Metvix cream.

Intervention Type DRUG

Metvix Vehicle Group

Participants were treated with topical administration of Metvix Vehicle cream.

Intervention Type DRUG

Other Intervention Names

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methyl aminolevulinate

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No