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

February 16, 2021 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Different application times of the study treatment are being investigated.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom
        • University of Manchester-Hope Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: Metvix PDT
Metvix PDT
Placebo Comparator: 2
Procedure: placebo
placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: CEM Griffiths, Professor, Manchester Hope Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 19, 2007

First Submitted That Met QC Criteria

February 19, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29057
  • eudract:2006-004237-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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