Skin cancer prevention in people who have had organ transplants by the use of treatment creams to get rid of actinic keratosis skin lesions (cancer precursors)- does this work?
- Conditions
- Actinic keratosis (and cutaneous squamous cell carcinoma)MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-000893-32-GB
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1. Organ Transplant Recipient (OTR) Patient Group:
•OTRs aged >18 years
•A minimum of 10 AK (with at least 5 AK occurring within the same skin zone)
•Demonstrably stable renal function on the basis of serum creatinine and estimated Glomerular Filtration Rate (eGFR)
•No recent change in immunosuppressive medication and predicted to remain stable over course of the study
•Able to apply topical cream as directed to the required area or having a carer who agrees to do this at the required frequency and times
•Women of child-bearing potential, or men in a relationship with a woman of child-bearing potential, prepared to adopt adequate contraceptive measures if sexually active
•Able to give written informed consent
•Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
2. Immunocompetent Patient Group (participating in the DCE substudy only):
•ICP patients aged >18 years
•Present or previous AK (any site, any number)
•Able to give written informed consent
•Willing to spend up at least 20 minutes completing the Long Q
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Organ Transplant Recipients (OTR) only:
•Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin (hCG) test performed to rule out pregnancy prior to trial entry)
•Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible
•Life expectancy less than 12 months
•Known hypersensitivity to 5-fluorouracil, imiquimod, sunscreen, or to any of the excipients (including but not limited to: methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, stearyl alcohol, polysorbate 60, propylene glycol, methyl parahydroxybenzoate and white soft paraffin)
•The use of brivudine, sorivudine and analogues is prohibited
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method