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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00473343
Registration number
NCT00473343
Ethics application status
Date submitted
14/05/2007
Date registered
15/05/2007
Date last updated
5/01/2023
Titles & IDs
Public title
Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma
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Scientific title
An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix® Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma
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Secondary ID [1]
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PC T310/00
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Metvix® cream
Experimental: Metvix® PDT - Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks.
Treatment: Drugs: Metvix® cream
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
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Assessment method [1]
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Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.
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Timepoint [1]
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3 months after last Metvix PDT cycle, up to 6 months
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Secondary outcome [1]
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Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle
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Assessment method [1]
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Complete response was defined as no clinically visible BCC lesions in the treatment area.
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Timepoint [1]
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3 months after last Metvix PDT cycle, up to 6 months
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Secondary outcome [2]
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Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
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Assessment method [2]
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Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:
excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin
good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin
fair: slight to moderate occurrence of scarring, atrophy or induration
poor: extensive occurrence of scarring, atrophy or induration.
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Timepoint [2]
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3 months after the last metvix PDT cycle, up to 6 months
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Secondary outcome [3]
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Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
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Assessment method [3]
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Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as:
excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.
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Timepoint [3]
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3 months after the last metvix PDT cycle, up to 6 months
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Secondary outcome [4]
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Recurrence Rate in Complete Clearance Group
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Assessment method [4]
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Recurrence rate in complete clearance(CC) group was analyzed.
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Timepoint [4]
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12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years
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Secondary outcome [5]
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Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
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Assessment method [5]
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Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:
excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.
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Timepoint [5]
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24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years
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Eligibility
Key inclusion criteria
- Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
- Males or females above 18 years of age.
- Written informed consent. AND
Participants with high risk of surgical complications due to:
- Anticoagulant medication or bleeding disorders
- Cardiac risk factors
- Anaesthetic contraindications
- Poor surgical compliance because of participant refusal, dementia, or inability to
perform wound care.
OR
• Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:
A large BCC lesion with the largest diameter:
- Equal to or greater than 15 mm on extremities, except below the knees, where largest
diameter should be equal to or greater than 10 mm
- Equal to or greater than 20 mm on the trunk
- Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zone
according to Swanson) or on the ear In participants with more then 6 eligible lesions,
the 6 lesions to be treated was randomly chosen.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior treatment of the lesion within 4 weeks.
- A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by
histology. A mixed nodular/morpheaform lesion which is not highly infiltrated
(clinically) may be included.
- Participant with porphyria.
- Pigmented lesions.
- Known allergy to Metvix® or a similar compound.
- Participation in another clinical study either concurrently or within the last 30 days
- Participant with Gorlin's syndrome.
- Participant with Xeroderma pigmentosum
- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative pregnancy test and use contraception during the treatments and for at least
one month thereafter).
- Conditions associated with a risk of poor protocol compliance.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2006
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Sample size
Target
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Accrual to date
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Final
102
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Department of Dermatology, St. George Hospital - Kogarah
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Recruitment hospital [2]
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South East Dermatology, The Belmont Specialist Clinic - Carnia
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Recruitment hospital [3]
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Department of Dermatology, Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Dermatology Department, The Queen Elisabeth Hospital - Adelaide
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Recruitment hospital [5]
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Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre - Heidelberg
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Recruitment hospital [6]
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Fremantle Dermatology - Fremantle
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Recruitment hospital [7]
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Dermatology Surgery & Laser Centre, The Perth Surgicentre - Perth
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Recruitment postcode(s) [1]
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NSW 2217 - Kogarah
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Recruitment postcode(s) [2]
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4152 - Carnia
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Recruitment postcode(s) [3]
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SA 5000 - Adelaide
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Recruitment postcode(s) [4]
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SA 5011 - Adelaide
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Recruitment postcode(s) [5]
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VIC 3081 - Heidelberg
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Recruitment postcode(s) [6]
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WA 6106 - Fremantle
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Recruitment postcode(s) [7]
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WA 6151 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Galderma R&D
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light
activation of a photosensitiser in the presence of oxygen. These cells accumulate more
photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon
illumination.
For skin diseases, there has been an increasing interest in using precursors of the
endogenous photoactive porphyrins. The most commonly used precursors have been
5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the
methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all
non-melanoma skin cancers. It is the most common cancer in humans. Several
non-pharmacological treatment modalities are used for BCC, including excision surgery,
curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation
therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on
the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good
response rates in the majority of participants but are inadequate in a small group of
participants defined as "high-risk" BCC.
In this particular participant group, even a moderate complete response rate with good
cosmetic results may be considered beneficial, since the number of participant who have to
receive more advanced therapy with the possibility of high morbidity and poor cosmetic
outcome was reduced. Even a partial response is of clinical interest since the remaining
tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does
not interfere with the use of other treatment modalities.
The variable "complete response" after one or two Metvix treatment cycles was used as the
basis for the justification of sample size.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00473343
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carl Vinciullo, MD
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Address
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Dermatology Surgery & Laser Centre, Perth
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00473343
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