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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00472043
Registration number
NCT00472043
Ethics application status
Date submitted
10/05/2007
Date registered
11/05/2007
Date last updated
6/08/2024
Titles & IDs
Public title
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma
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Scientific title
A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
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Secondary ID [1]
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PC T308/00
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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
Experimental: Metvix® cream 160 milligram per gram - Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm\^2.
Placebo comparator: Placebo - Participants with primary nodular basal cell carcinoma received Metvix® matching placebo cream. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm\^2.
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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 Complete Response (CR)
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Assessment method [1]
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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. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearance of lesion. Percentage of participants with histologically confirmed complete response were reported.
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Timepoint [1]
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up to 6 months
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Secondary outcome [1]
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Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response
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Assessment method [1]
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Histological response weight means no signs of malignant basal cells in all microscopical slides containing excised tissue. The histologically confirmed participant weighted response, weighted by percentage of lesions per participant are reported in this outcome measure. Number of lesions per participant with-in treatment group were calculated in following way: ni = number of lesions within 1 participant, ci= number of lesions in complete response within 1 participant, xi= 100%. ci/ni= response rate within one participant, Nt= number of participant within one treatment, nt=number of lesions with-in one treatment, wi=ni/nt= weight for one participant with Nt S wi (i=1) = 1 for each treatment.
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Timepoint [1]
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Up to 3 months
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Secondary outcome [2]
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Histological Lesion Response
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Assessment method [2]
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Histological examination included from the excised tissue were examined for presence of malignant basal cells, where complete response (CR) was no signs of malignant basal cells and non-CR was evidence of malignant basal cells
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Timepoint [2]
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Up to 3 months
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Secondary outcome [3]
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Percentage of Participants With Clinically Confirmed Participant Complete Response (CR)
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Assessment method [3]
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A CR to treatment was documented clinically by visual evaluation and palpation. The on-site investigator evaluated the lesion response by comparing with the lesion size before treatment using the following definitions: CR - complete disappearance of a lesion. Partial response (PR) -the longest diameter of the lesion is reduced by 50% or more. No response (NR) - the longest diameter of the lesion is less than 50% reduced. Progression - the longest diameter is increased by 20% or more.
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Timepoint [3]
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Up to 9 months
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Secondary outcome [4]
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Cosmetic Outcomes for Lesions Assessed by Investigator
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Assessment method [4]
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Cosmetic outcome for those lesions with complete histological response was assessed by both the investigator and by the participant. Cosmetic outcome was assessed with regards to occurrence of the following signs or symptoms like scarring, atrophy, induration, redness, and change in pigmentation. The cosmetic outcome was graded as excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared to 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 [4]
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Up to 3 months
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Secondary outcome [5]
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Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
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Assessment method [5]
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An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
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Timepoint [5]
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Up to 6 months
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Secondary outcome [6]
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Cosmetic Outcomes for Lesions Assessed by Participants
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Assessment method [6]
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Cosmetic outcome for those lesions with complete histological response was assessed by both the investigator and by the participant. Cosmetic outcome was assessed with regards to occurrence of the following signs or symptoms like scarring, atrophy, induration, redness, and change in pigmentation. The cosmetic outcome was graded as excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared to 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 [6]
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Up to 3 months
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Eligibility
Key inclusion criteria
A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with
* Clinically diagnosed primary nodular BCC lesion(s).
* Histologically confirmed diagnosis of BCC.
* BCC lesions suitable for simple excision surgery.
* Males or females above 18 years of age.
* Written informed consent.
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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
A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
* Participants with porphyria.
* Participant with Gorlin's syndrome.
* Participant with Xeroderma pigmentosum.
* Participants concurrently receiving immunosuppressive medication.
* Participants with a history of arsenic exposure.
* Known allergy to Metvix®, a similar PDT compound or excipients of the cream.
* Participation in other clinical studies either concurrently or within the last 30 days.
* Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
* Conditions associated with a risk of poor protocol compliance.
Lesion
* A nodular BCC lesion in periorbital area, ears and nasolabial fold.
* A nodular BCC lesion with the longest diameter less than 6 mm or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
* Pigmented nodular BCC lesion(s).
* Morpheaform nodular BCC lesion(s).
* Infiltrating nodular BCC lesion(s).
* Prior treatment of the BCC lesion(s).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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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
1/10/2000
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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
30/09/2002
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Sample size
Target
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Dept. of Dermatology, Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Dermatology Dept., St. George Hospital - Kogarah
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Recruitment hospital [3]
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Dermatology Centre - Liverpool
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Recruitment hospital [4]
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Dr. Michael Freeman - Benowa
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Recruitment hospital [5]
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Dermatology Dept., Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [6]
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Department of Dermatology, St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [7]
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Fremantle Dermatology - Fremantle
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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4217 - Benowa
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Recruitment postcode(s) [5]
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- Woolloongabba
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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6160 - Fremantle
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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) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors had been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity . In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive porphyrins induced cytotoxic effects in tumour cells after photoactivation. The primary objective was to compare PDT with Metvix® cream to PDT with placebo cream in terms of participant complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives were to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.
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Trial website
https://clinicaltrials.gov/study/NCT00472043
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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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Peter Foley, MD
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Address
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Department of Dermatology, St. Vincent's Hospital Melbourne
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00472043
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