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Trial registered on ANZCTR


Registration number
ACTRN12609000622202
Ethics application status
Not yet submitted
Date submitted
22/07/2009
Date registered
27/07/2009
Date last updated
27/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy and safety of 5% 5-Fluorouracil Cream in Renal Transplant patients for the treatment of actinic keratoses
Scientific title
In renal transplant patients, is 5% 5-Fluorouracil Cream effective and safe for the treatment of actinic keratoses?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 237336 0
Condition category
Condition code
Skin 239659 239659 0 0
Dermatological conditions
Renal and Urogenital 239670 239670 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5% 5-Fluorouracil Cream applied topically to areas affected by actinic keratoses within forehead, twice daily for 3 weeks
Intervention code [1] 236999 0
Treatment: Drugs
Comparator / control treatment
Clearance rates in comparable studies (comparing to a) all studies conducted to present that have evaluated the efficacy of 5% 5-Fluorouracil to treat actinic keratoses in healthy individuals, and also comparing to b) all studies conducted to present that have evaluated other treatments for actinic keratoses amongst the renal transplant population - i.e. First and second generation topical retinoids, imiquimod, diclofenac and methyl aminolaevulinate with photodynamic therapy).
Control group
Historical

Outcomes
Primary outcome [1] 238434 0
% complete clearance rates in surface area of Actinic keratoses at 12 months
The surface area will be mapped on a 1mm squared plastic film before and after treatment. Photographs will also be taken before and after treatment.
Timepoint [1] 238434 0
12 months following start of treatment
Primary outcome [2] 238435 0
% complete clearance rates in surface area of Actinic keratoses at 8 weeks
The surface area will be mapped on a 1mm squared plastic film before and after treatment. Photographs will also be taken before and after treatment.
Timepoint [2] 238435 0
8 weeks following start of treatment
Secondary outcome [1] 244935 0
% partial clearance rates (75-99%) in surface area of Actinic keratoses at 12 months
The surface area will be mapped on a 1mm squared plastic film before and after treatment. Photographs will also be taken before and after treatment.
Timepoint [1] 244935 0
12 months following start of treatment
Secondary outcome [2] 244936 0
% partial clearance rates (75-99%) in surface area of Actinic keratoses at 8 weeks
The surface area will be mapped on a 1mm squared plastic film before and after treatment. Photographs will also be taken before and after treatment.
Timepoint [2] 244936 0
8 weeks following start of treatment

Eligibility
Key inclusion criteria
- Patient must have received one or more kidney transplants >12 months ago
- Patient with one or more clinically typical, visible and discrete actinic keratosis (AK) lesions within the forehead area. This is the area that routinely undergoes initial treatment in patients with AK.
- Patient is male or female and at least 18 years of age.
- Female patient must be either of:
- Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility
- Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment. Patient must also consent to using effective contraception for the duration of study participation. Effective contraception is defined as injectable/implantable hormones; intrauterine device; trans-abdominal surgical sterilisation; sterilisation implant device; surgical sterilisation of male partner; or complete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study.
- Patient must demonstrate competence to give informed consent and comply with the dosage, visit and feedback requirements.
- Patient has provided informed consent documented by signing the Informed Consent Form, including consent for photographs to be taken and used as part of the study data package.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence on the forehead of an incompletely healed wound or a Basal Cell Carcinoma/Squamous Cell Carcinoma.
- Treatment area lesions with an atypical clinical appearance (e.g. hypertrophic, hyperkeratotic [>3mm thickness], and/or cutaneous horns.
- History or evidence of skin conditions other than the study indication that would interfere with the evaluation of the effect of the study medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
- Clinical diagnosis/history or evidence of any medical condition that would expose a patient to an undue risk of a significant adverse effect or interfere with assessments of safety and efficacy during the study.
- Anticipated need for in-patient hospitalisation/surgery during the first 21 days of the study.
- Known sensitivity or allergy to any of the ingredients of 5-Fluorouracil.
- Anticipated excessive exposure to Ultraviolet light (e.g. sunlight) or the use of tanning beds during the 21-day duration of the study.
- Current enrolment or participation in a clinical study within 30 days of entry into this study and throughout the duration of the study.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will not occur in this trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)

Funding & Sponsors
Funding source category [1] 237384 0
Hospital
Name [1] 237384 0
The Dermatology Trust Fund
Address [1] 237384 0
c/o The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, SA 5011
Country [1] 237384 0
Australia
Primary sponsor type
Individual
Name
Dr Warren Weightman
Address
161 Ward Street, North Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 236884 0
Individual
Name [1] 236884 0
Annabel Ingham
Address [1] 236884 0
c/o Medical School, The University of Adelaide, SA 5000
Country [1] 236884 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239516 0
Ethics of Human Research Committee
Ethics committee address [1] 239516 0
c/o Ethics of Human Research Committee, 28 Woodville Road, Woodville South, SA, 5011
Ethics committee country [1] 239516 0
Australia
Date submitted for ethics approval [1] 239516 0
03/08/2009
Approval date [1] 239516 0
Ethics approval number [1] 239516 0
N/A

Summary
Brief summary
Actinic keratosis are scaly patches on sun-exposed skin, especially the face, scalp and backs of hands. They are usually grey to dark pink in colour and if left unattended, may develop into skin cancer.

5-Fluorouracil is a man-made drug that is currently in widespread use in the non-transplant population as a topical therapy for actinic keratoses. The purpose of this study is to look at how effective 5-Fluorouracil is at reducing the number of actinic keratoses in renal transplant patients.

5-Fluorouracil has been widely tested in the non-transplant population. It is recognised as being a successful therapeutic agent with two randomised controlled trials finding that patients had a 70-78% reduction in lesions following treatment. It is applied topically over a three week period to the area affected by actinic keratoses.

This study will help to provide more information on 5-Fluorouracil. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in renal transplant patients that suffer from pre-cancerous skin lesions.

This study drug is approved by the Therapeutic Goods Act for use in the general population and has been used for many years in renal transplant patients. The side effects are well known.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 29952 0
Address 29952 0
Country 29952 0
Phone 29952 0
Fax 29952 0
Email 29952 0
Contact person for public queries
Name 13199 0
Dr Warren Weightman
Address 13199 0
161 Ward Street, North Adelaide, SA, 5006
Country 13199 0
Australia
Phone 13199 0
+61 8 8360 7888
Fax 13199 0
Email 13199 0
wweightman@dermward.com.au
Contact person for scientific queries
Name 4127 0
Dr Warren Weightman
Address 4127 0
161 Ward Street, North Adelaide, SA, 5006
Country 4127 0
Australia
Phone 4127 0
+61 8 8360 7888
Fax 4127 0
Email 4127 0
wweightman@dermward.com.au

No information has been provided regarding IPD availability
Summary results
No Results