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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

Primary Purpose

Field Actinic Keratoses, Basal Cell Carcinoma, Bowen's Disease

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Metvix (methyl aminolevulinate)
Sponsored by
Galderma R&D
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Field Actinic Keratoses focused on measuring actinic, keratoses, superficial, basal, carcinomas, Bowen's, large or multiple superficial Basal Carcinomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2007
    Last Updated
    February 16, 2021
    Sponsor
    Galderma R&D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00535080
    Brief Title
    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
    Official Title
    Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Galderma R&D

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Field Actinic Keratoses, Basal Cell Carcinoma, Bowen's Disease
    Keywords
    actinic, keratoses, superficial, basal, carcinomas, Bowen's, large or multiple superficial Basal Carcinomas

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Metvix (methyl aminolevulinate)
    Intervention Description
    Metvix (methyl aminolevulinate) (MAL), Photodynamic Therapy (PDT), cream, 160 mg/g. MAL cream will be applied for 3 hours then will be removed. The target area will then be exposed to red light (using a large-field LED light source: Aktilite 128) for 7 to 10 minutes at a dosage of 37 J/cm².

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Links:
    URL
    http://www.galderma.com/
    Description
    Related Info

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    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

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