MATERIALS AND METHODS
Patients applied tretinoin cream (0.1%) twice daily over entire face including ears for a period of 1 year. Recruitment period was from 1st November 1998 up to 1st November 2002. Patient follow up was done till 15th November 2004. Data was analyzed by various statistical methods.
A total of 1131 patients were randomized. For tretinoin treatment group, 566 patients were recruited. The remaining patients received a placebo cream. Primary end point of the study was occurrence of new SCC or BCC. Monitoring of mortality was done.