Specialty pharmaceutical company LEO Pharma today announced that findings from a Phase III study evaluating PEP005 (ingenol mebutate) Gel 0.05% to treat actinic keratosis (AK), a common pre-cursor to skin cancer, were presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) (Scientific Session Poster Discussion: P105). Results from REGION-I demonstrated treatment with PEP005 Gel once daily for 2 consecutive days.
"Cryotherapy has been the gold standard for actinic keratosis for some time, with topical agents also used over a period of weeks to months. Findings from the REGION-I study suggest that PEP005, a topical Gel administered over just two days, may provide a safe and effective alternative to current therapies," said Neil Swanson, M.D., Department Chairman and Professor of Dermatology, Surgery and Otolaryngology at Oregon Health & Sciences University, and REGION-I principal investigator.
Patients in REGION-I were randomized to receive either PEP005 Gel applied topically as monotherapy to body AK lesions once daily for 2 consecutive days or vehicle. Patients were evaluated on days 3, 8, 15, 29 and 57. The primary objective was to compare the efficacy, as measured by complete clearance, of PEP005 Gel with the vehicle. The secondary objective was the partial clearance of AK lesions. Safety was also assessed by the incidence rate of adverse events (AEs) serious adverse events (SAEs) and AEs leading to discontinuation, as well as by the incidence rate and grade of Local Skin Responses (LSRs), pigmentation and scarring.