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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00472043




Registration number
NCT00472043
Ethics application status
Date submitted
10/05/2007
Date registered
11/05/2007
Date last updated
3/09/2010

Titles & IDs
Public title
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
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 Patients With Primary Nodular Basal Cell Carcinoma.
Secondary ID [1] 0 0
PC T308/00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - PDT with Metvix 160 mg/g cream and Placebo cream

Treatment: Surgery: PDT with Metvix 160 mg/g cream and Placebo cream


Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely).
Timepoint [1] 0 0
6 months after last treatment
Secondary outcome [1] 0 0
Histological and clinical mean patient response rates weighted for the number of lesions within a patient
Timepoint [1] 0 0
3 and 6 months after last treatment
Secondary outcome [2] 0 0
Histological and clinical number of lesions across patients that show complete response
Timepoint [2] 0 0
3 and 6 months after last treatment
Secondary outcome [3] 0 0
Clinical complete patient response
Timepoint [3] 0 0
3 and 6 months after last treatment
Secondary outcome [4] 0 0
Evaluation of cosmetic outcome
Timepoint [4] 0 0
3 and 6 months after last treatment
Secondary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0
2 weeks, 4 weeks and 3 months after each treatment cycle

Eligibility
Key inclusion criteria
A patient with primary, nodular BCC lesion(s) suitable for entry is defined as a patient
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient that is ineligible for inclusion is a patient fulfilling any of the following
criteria:

- Patient with porphyria.

- Patient with Gorlin's syndrome.

- Patient with Xeroderma pigmentosum

- Patients concurrently receiving immunosuppressive medication

- Patients 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Dept. of Dermatology, Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Dermatology Dept., St. George Hospital - Kogarah
Recruitment hospital [3] 0 0
Dermatology Centre - Liverpool
Recruitment hospital [4] 0 0
Dr. Michael Freeman - Benowa
Recruitment hospital [5] 0 0
Dermatology Dept., Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Department of Dermatology, St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galderma
Address
Country

Ethics approval
Ethics application status

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 photosensitiser protoporphyrin IX (PpIX). 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 .

In vitro studies of animal and human tissues have 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 is to compare PDT with Metvix® cream to PDT with placebo cream in terms
of patient complete response rates based on histologically verified disappearance of the
lesions at 6 months after last treatment cycle.

Secondary objectives are to compare the two treatments in terms of histological and clinical
mean patient response weighted by the number of lesions within a patient, lesion response
rates across patients, clinical complete patient response, cosmetic outcome and adverse
events.
Trial website
https://clinicaltrials.gov/show/NCT00472043
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Foley, MD
Address 0 0
Department of Dermatology, St. Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications