Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000192583
Ethics application status
Approved
Date submitted
23/05/2006
Date registered
24/05/2006
Date last updated
21/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase IIa safety study of topical R-flurbiprofen in patients with a history of non-melanoma skin cancer
Scientific title
A randomised, double blind, placebo controlled, Phase IIa study of the safety of R-flurbiprofen administered as a topical gel to patients with a history of non-melanoma skin cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-melanoma skin cancer 1167 0
Condition category
Condition code
Cancer 1252 1252 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. Thirty subjects will receive the R-flurbiprofen gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands.
Intervention code [1] 1068 0
Prevention
Comparator / control treatment
10 will receive a placebo gel
Control group
Placebo

Outcomes
Primary outcome [1] 1690 0
This is a safety and tolerability trial of a topically-applied gel. The primary outcome will be skin irritation at the sites of administration.
Timepoint [1] 1690 0
Assessments will be conducted after 1, 2 and 4 weeks of application.
Secondary outcome [1] 3031 0
Adverse events
Timepoint [1] 3031 0
Assessed throughout the trial
Secondary outcome [2] 3032 0
Systemic absorption of R-flurbiprofen
Timepoint [2] 3032 0
Assessed at weeks 2 and 4.

Eligibility
Key inclusion criteria
Must have had at least one non-melanoma skin cancer in the past 5 years.
Minimum age
40 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any significant medical disorder;Current use of NSAIDs (and unwilling to cease use).

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



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
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] 1366 0
Commercial sector/Industry
Name [1] 1366 0
PharmaQest Pty Ltd
Country [1] 1366 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PharmaQest Pty Ltd
Address
Reid Building, UniSA
Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 1206 0
None
Name [1] 1206 0
Nil
Address [1] 1206 0
Country [1] 1206 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35169 0
Address 35169 0
Country 35169 0
Phone 35169 0
Fax 35169 0
Email 35169 0
Contact person for public queries
Name 10257 0
Dr Peter Wigley
Address 10257 0
PharmaQest
Reid Building, University of South Australia
Frome Road
Adelaide SA 5000
Country 10257 0
Australia
Phone 10257 0
+61 8 83021224
Fax 10257 0
Email 10257 0
peter@pharmaqest.com.au
Contact person for scientific queries
Name 1185 0
Dr Peter Wigley
Address 1185 0
PharmaQest
Reid Building, University of South Australia
Frome Road
Adelaide SA 5000
Country 1185 0
Australia
Phone 1185 0
+61 8 83021224
Fax 1185 0
Email 1185 0
peter@pharmaqest.com.au

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.