Not Yet RecruitingPhase 4ACTRN12609000622202

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?


Sponsor

Dr Warren Weightman

Enrollment

20 participants

Start Date

Sep 1, 2009

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a topical cream containing 5-Fluorouracil is safe and effective for treating sun damage spots (actinic keratoses) on the forehead of people who have received a kidney transplant. It is for adults aged 18 and over who received their transplant at least 12 months ago. People with skin cancer on the forehead, allergies to the cream, or other interfering skin conditions cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

5% 5-Fluorouracil Cream applied topically to areas affected by actinic keratoses within forehead, twice daily for 3 weeks

5% 5-Fluorouracil Cream applied topically to areas affected by actinic keratoses within forehead, twice daily for 3 weeks


Locations(1)

Australia

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ACTRN12609000622202


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