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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
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
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
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Histologically Confirmed Complete Response (CR)
Timepoint [1] 0 0
up to 6 months
Secondary outcome [1] 0 0
Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [2] 0 0
Histological Lesion Response
Timepoint [2] 0 0
Up to 3 months
Secondary outcome [3] 0 0
Percentage of Participants With Clinically Confirmed Participant Complete Response (CR)
Timepoint [3] 0 0
Up to 9 months
Secondary outcome [4] 0 0
Cosmetic Outcomes for Lesions Assessed by Investigator
Timepoint [4] 0 0
Up to 3 months
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
Timepoint [5] 0 0
Up to 6 months
Secondary outcome [6] 0 0
Cosmetic Outcomes for Lesions Assessed by Participants
Timepoint [6] 0 0
Up to 3 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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
1/10/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2002
Sample size
Target
Accrual to date
Final
66
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 R&D
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00472043