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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00437320
First received: February 19, 2007
Last updated: January 6, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Photoaged Skin
Procedure: Metvix PDT
Procedure: placebo
Phase 2

Study Type: 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
Official Title: Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin

Resource links provided by NLM:


Further study details as provided by Galderma:

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

Estimated Enrollment: 45
Study Start Date: March 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Metvix PDT
Metvix PDT
Placebo Comparator: 2 Procedure: placebo
placebo

Detailed Description:

Different application times of the study treatment are being investigated.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00437320     History of Changes
Other Study ID Numbers: RD.03.SPR.29057, eudract:2006-004237-15
Study First Received: February 19, 2007
Last Updated: January 6, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines

Keywords provided by Galderma:
PDT
Photoaging
Galderma

Additional relevant MeSH terms:
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 16, 2014