Pilot Study Evaluation of a Combination of Topical 5-Fluorouracil [5FU] and Calcipotriol in the Treatment of Cutaneous Actinic Keratosis [AK] and Intraepidermal Carcinoma [IEC] Lesions
Dr Leith Banney
30 participants
Oct 1, 2021
Interventional
Conditions
Summary
Cutaneous Actinic Keratosis (AK) and Intraepidermal Carcinoma (IEC) lesions are precursors of skin cancer. This study aims to assess the effectiveness of 5FU (EfudixTM) skin cream alone, compared to a combined 5FU-calcipotriol skin cream, for treating these skin cancer precursors. Who is it for? You may be eligible for this study if you are aged between 18 to 85 years, and you have skin cancer precursors of AK and IEC lesions. People who have been diagnosed with skin cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will be asked to apply the single skin cream on one side of the face, and the combined skin cream on the other side of the face. Each cream will be applied twice daily. The single cream will be used for 2-4 weeks, as tolerated; while the combined cream will be used for 4-6 days. The allocation of the side of the face (left/right) to the cream treatment will be random. After 3 months, 1 year, and 2 years, we will ask for your preference of either the single or double cream, and assess changes in the skin cancer precursor lesions. It is hoped this research will determine the effectiveness of a combined skin cream in treating skin cancer precursors, which may reduce the risk of developing skin cancer.
Eligibility
Inclusion Criteria6
- Adults aged 18-85 years.
- Extensive solar damage to skin over the face, as determined by a dermatologist.
- Ability to comply with treatment regime as determined by the treating investigator.
- Ability to undertake written informed consent prior to initiation of study protocol.
- Ability/willing to attend follow up clinic visits that will include clinical photography.
- Able to complete study surveys.
Exclusion Criteria4
- Patients commencing acitretin, other oral or topical retinoids or oral vitamin B3 in the past 3 months and for the duration of the study.
- Patients with known allergy/hypersensitivity to 5FU cream.
- Patients with known dihydropyrimidine dehydrogenase (DPD enzyme) deficiency.
- Patients who are pregnant or breastfeeding. Female participants should avoid pregnancy and breastfeeding during use of treatment cream until three-month review.
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Interventions
Experimental Treatment Cream made up of Fluorouracil 5% plus Calcipotriol 0.005% Cream This is an open label, prospective study comparing two topical treatments for skin cancer precursors using a blinded investigator and clinical photography to determine treatment outcome. Consenting participants will be randomised to receive either twice daily combined topical 5FU-calcipotriol cream to the left or right side of the face, and topical 5FU (EfudixTM) to the alternate side of the face. The 5FU-calcipotriol cream will be used for 4 days for AK lesions, and for 6 days for IEC lesions. The 5FU (EfudixTM) will be used on AK and IEC lesions for 2-4 weeks, as tolerated (as per current clinical practice). The participants will be applying the creams themselves at home (as per standard of care for topical treatments of skin cancer precursors. As per standard guidelines for use of topical 5 fluorouracil, participants will be advised to apply one "pea sized" amount of cream to each cheek (left and right), forehead and chin. To monitor adherence to treatment, patients will complete a treatment cream diary throughout the duration of treatment.
Locations(1)
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ACTRN12621001242819