The efficacy and safety of 5% 5-Fluorouracil Cream in Renal Transplant patients for the treatment of actinic keratoses

Phase 4

• Conditions: Actinic Keratosis; Skin - Dermatological conditions; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12609000622202
• Lead Sponsor: Dr Warren Weightman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

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

• Study Type: Interventional
• Study Design: Not specified