Clinical Trial Design and Outcome Measures (L Naldi, Section Editor)

Current Dermatology Reports

, Volume 1, Issue 3, pp 123-130

First online:

Skin Cancer Prevention: Recent Evidence from Randomized Controlled Trials

  • Adèle C. GreenAffiliated withCancer and Population Studies Group, Queensland Institute of Medical ResearchUniversity of Manchester, Manchester Academic Health Sciences CentreQueensland Institute of Medical Research, PO Royal Brisbane Hospital Email author 
  • , Catherine A. HarwoodAffiliated withCentre for Cutaneous Research, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
  • , John LearAffiliated withDepartments of Dermatology, Salford Royal NHS Foundation Trust and Manchester Royal Infirmary and University of Manchester
  • , Charlotte ProbyAffiliated withDivision of Cancer Research, Medical Research Institute, University of Dundee, Ninewells Hospital & Medical School
  • , Sudipta SinnyaAffiliated withDermatology Research Centre, The University of Queensland, School of Medicine, Princess Alexandra Hospital
  • , H. Peter SoyerAffiliated withDermatology Research Centre, The University of Queensland, School of Medicine, Princess Alexandra Hospital


Despite the billions of health care dollars spent each year on treating skin cancer, there is a dearth of randomized controlled trials (RCTs) that have evaluated skin cancer prevention. RCTs published in the last 3 years that have directly assessed skin cancer prevention as their primary aim suggest that regular use of sunscreen is cost effective, but prolonged use of topical therapies such as tretinoin and 5-fluorouracil may not be. Sirolimus-based immunosuppression for secondary skin cancer prevention in long-term renal transplant recipients appears effective, but benefits may be offset by the adverse effects. Many RCTs using pre-invasive actinic keratoses (AKs) as endpoints are too small and/or too short to provide evidence on skin cancer prevention. Another stumbling block is the difficulty in reproducibly diagnosing and counting AKs in response to preventive agents. Longer term and better surveillance methods are urgently required to improve the quality of evidence from future RCTs.


Skin cancer Prevention Randomized controlled trials RCTs Clinical trials Outcome measures Interventions Sunscreen Topical treatment Basal cell carcinoma BCC Squamous cell carcinoma SCC Actinic keratosis AK 5-fluorouracil 5-FU Digital photography Dermoscopy