Peplin, Inc. (ASX:PLI) announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities. This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.
This second pivotal Phase 3 trial for non-head locations, known as REGION-Ib, enrolled approximately 200 patients. It is designed to replicate the recently completed REGION-I trial and confirm the results of that trial in which PEP005 Gel, 0.05%, demonstrated a total clearance rate across all anatomical non-head locations of 27.4% (p