Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease

February 16, 2021 updated by: Galderma R&D

Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease

The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subject older than 18 years.

  • Subject presenting with:

    • Either field actinic keratoses (AKs) (mild to moderate, multiple and clustered AKs on a severely sun-damaged skin); or
    • Biopsy-confirmed large, or multiple (several in the same anatomical area) primary superficial BCC lesions that are macroscopically and histologically consistent with superficial basal cell carcinoma (sBCC) and have no histological evidence of aggressive growth patterns; or
    • Histologically confirmed diagnosis of Bowen's disease from a biopsy taken within 3 months
  • Any subject presenting with the aforementioned lesions must not be able to be treated optimally by conventional therapies.
  • Female subject of childbearing potential, using an effective birth control method (see Case Report Form) and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential
  • Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
  • Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.

Exclusion Criteria:

  • A recurrent superficial BCC lesion that has previously been treated.

  • Subject whose lesions on the selected treatment zone (including a 5 cm margin around the treatment area) have been treated with any of the following topical treatments within the specified washout period:

    • 5-FU - 3 months
    • Cryotherapy - 3 months
    • Imiquimod - 3 months
    • PDT - 3 months
    • Diclofenac sodium - 3 months
    • Surgery, radiotherapy, curettage, electrodesiccation, retinoids, dermabrasion, laser resurfacing, salicylic acid - 3 months
  • A primary superficial BCC located close to or involving a scar of SCC
  • Subject with known porphyria.
  • Subject with target lesions on the genitals.
  • Subject with known xeroderma pigmentosum.
  • Pigmented lesion(s) on the treated area.
  • Morpheaform lesion(s) on the treated area.
  • Infiltrating lesion(s) on the treated area.
  • Female subject who is pregnant, nursing or planning a pregnancy during the study.
  • Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream.
  • Subject who has participated in another investigational drug or device research study within 30 days of enrolment.

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?

Collaborators and Investigators

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

Sponsor

Galderma R&D

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 Registration Dates

First Submitted

September 21, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (ESTIMATE)

September 26, 2007

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAN.15.SPR.001

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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