Clinical trial NCT00437320: Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin
Official title: Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Photoaged Skin
Keywords: PDT
Photoaging
Galderma
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Severity of Photodamage
timeFrame: At Week 20
measure: Number of Participants With Severity of Mottled Hyper-Pigmentation
timeFrame: At Week 20
measure: Number of Participants With Severity of Fine Lines
timeFrame: At Week 20
measure: Number of Participants With Severity of Telangiectasia
timeFrame: At Week 20
measure: Number of Participants With Severity of Skin Roughness
timeFrame: At Week 20
measure: Number of Participants With Severity of Skin Laxity
timeFrame: At Week 20
measure: Number of Participants With Tolerability Assessment of Erythema
timeFrame: At Week 20
measure: Number of Participants With Tolerability Assessment of Edema
timeFrame: At Week 20
measure: Number of Participants With Tolerability Assessment of Oozing/Crusting
timeFrame: At Week 20
measure: Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)
timeFrame: At Week 4
measure: Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)
timeFrame: At Week 8
measure: Number of Participants With Tolerability Assessment of Scaling
timeFrame: At Week 20
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Week 20
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Policlinico Ruber
city: London
country: United Kingdom
facility: Whittington Hospital
city: Manchester
country: United Kingdom
facility: University of Manchester-Hope Hospital
Study officials:
affiliation: Professor
name: CEM Griffiths
role: PRINCIPAL_INVESTIGATOR
References: