Know Cancer

or
forgot password

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


Phase 2
30 Years
N/A
Not Enrolling
Both
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
protocol

- 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:

Interventional

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:

Yes

Principal Investigator

CEM Griffiths, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Manchester Hope Hospital

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

RD.03.SPR.29057

NCT ID:

NCT00437320

Start Date:

March 2007

Completion Date:

September 2008

Related Keywords:

  • Photoaged Skin
  • PDT
  • Photoaging
  • Galderma

Name

Location