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

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ClinicalTrials.gov Identifier: NCT00437320
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : January 7, 2009
Sponsor:
Information provided by:
Galderma

Brief Summary:

Skin photoaging or skin photodamage are 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 are 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 are presenting to doctors with concerns about skin photodamage and the demand for corrective procedures is 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 (e.g. actinic keratosis).

The aim of the study is to assess whether Metvix® PDT will be effective in correcting the effects related to photodamage and whether it will be well tolerated.


Condition or disease Intervention/treatment Phase
Photoaged Skin Procedure: Metvix PDT Procedure: placebo Phase 2

Detailed Description:
Different application times of the study treatment are being investigated.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Procedure: Metvix PDT
Metvix PDT
Placebo Comparator: 2 Procedure: placebo
placebo



Primary Outcome Measures :
  1. Efficacy and safety parameters (e.g.: severity of photodamage, severity of fine lines, erythema, etc.) [ Time Frame: every four weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437320


Locations
United Kingdom
University of Manchester-Hope Hospital
Manchester, United Kingdom
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: CEM Griffiths, Professor Manchester Hope Hospital

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00437320     History of Changes
Other Study ID Numbers: RD.03.SPR.29057
eudract:2006-004237-15
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by Galderma:
PDT
Photoaging
Galderma

Additional relevant MeSH terms:
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents