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Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin

Phase 2
30 Years
Not Enrolling
Photoaged Skin

Thank you

Trial Information

Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin

Different application times of the study treatment are being investigated.

Inclusion Criteria:

- Male or female subjects older than 30 years of age.

- Subjects with a photodamage grade of at least 4 on the Griffiths photonumeric scale
(symmetrical photodamage on the two target areas)

- Subjects with mottled hyper-pigmentation on the face

- Subjects willing and capable of cooperating to the extent and degree required by the

- Subjects must read the Patient Information Sheet and read and sign the Informed
Consent form prior to any study related procedures.

Exclusion Criteria:

- Subjects who are at risk in terms of precautions, warnings, and contra-indication in
the package insert for Metvix®

- Subjects with suspected porphyria

- Subjects with specific wash-out period for interfering treatments

- Subjects requiring concurrent treatment that would interfere with study objectives
and/or evaluations

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Efficacy and safety parameters (e.g.: severity of photodamage, severity of fine lines, erythema, etc.)

Outcome Time Frame:

every four weeks

Safety Issue:


Principal Investigator

CEM Griffiths, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Manchester Hope Hospital


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

March 2007

Completion Date:

September 2008

Related Keywords:

  • Photoaged Skin
  • PDT
  • Photoaging
  • Galderma