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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Galderma. Recruitment status was No longer available

First Received on September 21, 2007. Last Updated on October 27, 2009 History of Changes

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00535080

Purpose

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.

Condition	Intervention
Field Actinic Keratoses Basal Cell Carcinoma Bowen's Disease	Drug: Metvix (methyl aminolevulinate)

Study Type:	Expanded Access What is Expanded Access?
Official Title:	Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease

Resource links provided by NLM:

Drug Information available for: Methyl aminolevulinate Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Further study details as provided by Galderma:

Intervention Details:

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.

Other Name: METVIX (methyl aminolevulinate)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Regulatory, Medical & Technical Affairs, Galderma Canada
ClinicalTrials.gov Identifier:	NCT00535080 History of Changes
Other Study ID Numbers:	CAN.15.SPR.001
Study First Received:	September 21, 2007
Last Updated:	October 27, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Galderma:

actinic
keratoses
superficial
basal

carcinomas
Bowen's
large or multiple superficial Basal Carcinomas

Additional relevant MeSH terms:

Bowen's Disease
Carcinoma
Carcinoma, Basal Cell
Keratosis
Keratosis, Actinic
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell

Skin Diseases
Precancerous Conditions
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012