Almirall presents positive new data on Actikerall for actinic keratosis

Spain’s largest drugmaker Almirall (ALM: MC) has announced positive data from a Phase III randomized, double-blind, vehicle-controlled study evaluating the efficacy and safety of its already marketed Actikerall (5-fluorouracil (5-FU) 0.5%/salicylic acid 10%) when applied once daily as field-directed treatment to actinic keratosis (AK) lesions.

The results have been presented at the 16th World Congress on Cancers of the Skin & 12th Congress of the European Association of Dermato Oncology (EADO).

Patients included in the study had a 25cm2 area of skin with 4-10 clinically confirmed AK lesions (grade I/II) either in their face, bald scalp or forehead. The trial met the primary efficacy endpoint with a significantly higher proportion of patients (49.5%) treated with Actikerall achieving complete skin clearance at 8 weeks after the end of the treatment compared with vehicle (18.2%, p=0.0006).