The efficacy and safety of 5% 5-Fluorouracil Cream in Renal Transplant patients for the treatment of actinic keratoses
In renal transplant patients, is 5% 5-Fluorouracil Cream effective and safe for the treatment of actinic keratoses?
Dr Warren Weightman
20 participants
Sep 1, 2009
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
5% 5-Fluorouracil Cream applied topically to areas affected by actinic keratoses within forehead, twice daily for 3 weeks
Locations(1)
View Full Details on ANZCTR
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ACTRN12609000622202