LEO Pharma reports positive Phase III data for ingenol mebutate gel in actinic keratosis

Privately-held Danish dermatology specialist LEO Pharma has announced the completion of the Phase III FIELD Study 1 – the largest ever, one year evaluation of field treatment with ingenol mebutate gel for actinic keratosis (AK) after initial cryosurgery of individual AK lesions, compared to cryosurgery followed by a vehicle gel.

The study involved more than 300 patients across 35 trial sites and is also the first to evaluate field treatment with ingenol mebutate gel subsequent to cryosurgery. LEO Pharma reported that the study met its efficacy and safety endpoints at 11 weeks and 12 months. The 11 week results are expected to be published by the end of 2013, with publication of the one year data expected in the first half of 2014.

Brian Berman, voluntary professor of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine in the USA, and lead investigator in the FIELD Study 1, said: “The results of this study are very promising. The 12 month data show sustained patient benefits beyond those the 11 week results indicated. These data provide important evidence for the beneficial role of Picato field-directed treatment in combination with cryosurgery, in achieving clearance of sub-clinical lesions in the field and preventing further AK lesion recurrence.”