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
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
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
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
Learn more about this trial
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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