Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study.

Abstract

Surgical procedures remain the gold standard for treating basal cell carcinoma (BCC), although commonly associated with cosmetic defects. The demand for noninvasive alternatives remains high. To determine efficacy and safety of red light photodynamic therapy (PDT) with 10% 5-aminolevulinic acid (ALA) gel vs vehicle for treatment of superficial BCC. This randomized, double-blind, vehicle-controlled, pivotal phase III study was conducted at 21 centers in the US. Eligible participants had ≥1 naïve superficial BCC and received 1-2 PDT cycles (2 PDTs each cycle) followed by clinical and histological assessment 12 weeks after start of the last PDT cycle. Of 187 randomized participants, 145 received PDT with 10% ALA gel and 42 with vehicle. Histological clearance was 75.9% with 10% ALA gel vs 19.0% with vehicle (P < .0001). Clinical clearance was 83.4% with 10% ALA gel vs 21.4% with vehicle (P < .0001). A total of 88.1% of participants treated with 10% ALA gel rated the esthetic outcome as very good or good. No previously unknown adverse events occurred. Few participants with lesions on face/scalp; to date, a 60-month follow-up is still ongoing. 10% ALA gel showed significantly higher clearance rates than vehicle with unproblematic safety and positive esthetic outcome.