Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000066088
Ethics application status
Approved
Date submitted
16/01/2010
Date registered
20/01/2010
Date last updated
20/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Lentigo Maligna with imiquimod 5% cream.
Scientific title
Treatment of Lentigo Maligna by imiquimod 5% cream as assessed by pathological assessment of the surgical excison specimen of the complete treated area
Secondary ID [1] 1308 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lentigo maligna 256564 0
Condition category
Condition code
Skin 256734 256734 0 0
Other skin conditions
Cancer 256768 256768 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
imiquimod 5% cream masaged directly into the lentigo maligna each day from Monday to Friday with breaks from treatment on Saturday and Sunday and any other day when the inflammation due to the cream is intolerable. This is done for 12 weeks.
Intervention code [1] 255832 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257616 0
clearance of lentigo maligna as demonstrated by histological assessment of the complete surgical excison specimen of the entire treated area post application of imiquimod
Timepoint [1] 257616 0
after the 12 weeks of imiquimod application an assessment is made and surgery is scheduled within the next 2 weeks depending on the expected time for the inflammation to settle as determined by the investigators
Secondary outcome [1] 262889 0
pathologist concordance in assessment of specimens
Timepoint [1] 262889 0
post surgical excision
Secondary outcome [2] 262890 0
relevance of inflammatory reaction to clearance of tumour as assessed by clinical review of the inflammatory reaction severity graded as none, mild , moderate or severe.
Timepoint [2] 262890 0
post surgical excision

Eligibility
Key inclusion criteria
lentigo maligna greater than 5mm diiameter
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
detection of invasive melanoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
full consent procedure for all eligible patients
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
noot randomized
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
use of two pathologists independently assessing diagnostic and end point specimens
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256324 0
Hospital
Name [1] 256324 0
Victorian Melanoma Service
Country [1] 256324 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Commercial Road
Prahran
Victoria 3181
Country
Australia
Secondary sponsor category [1] 251642 0
Commercial sector/Industry
Name [1] 251642 0
iNova
Address [1] 251642 0
9-15 Chilvers Road
Thornleigh
New South Wales 2120
Country [1] 251642 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258405 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 258405 0
Commercial Road
Prahran
Victoria 3181
Ethics committee country [1] 258405 0
Australia
Date submitted for ethics approval [1] 258405 0
01/06/2005
Approval date [1] 258405 0
17/12/2005
Ethics approval number [1] 258405 0
1/05/0174

Summary
Brief summary
The objective of the study is to determine how effective imiquimod cream is in curing lentigo maligna and whether it is a possible replacement for surgical excison as the primary treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30714 0
Address 30714 0
Country 30714 0
Phone 30714 0
Fax 30714 0
Email 30714 0
Contact person for public queries
Name 13961 0
Dr Martin Haskett
Address 13961 0
PO Box 7239
Karingal Centre
Vicotria 3199
Country 13961 0
Australia
Phone 13961 0
613 9770 9788
Fax 13961 0
613 9770 9755
Email 13961 0
[email protected]
Contact person for scientific queries
Name 4889 0
Martin Haskett
Address 4889 0
PO Box 7293
Karingal Centre
Victoria 3199
Country 4889 0
Australia
Phone 4889 0
613 9770 9788
Fax 4889 0
613 9770 9755
Email 4889 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.