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
Inclusion Criteria8
- 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.
Exclusion Criteria8
- 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.
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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