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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
Trial website
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

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