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

Document Type

Article

Publication Date

8-20-2025

Publication Title

Journal of the American Academy of Dermatology

Abstract

BACKGROUND: 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.

OBJECTIVE: 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.

METHODS: 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.

RESULTS: 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.

LIMITATIONS: Few participants with lesions on face/scalp; to date, a 60-month follow-up is still ongoing.

CONCLUSION: 10% ALA gel showed significantly higher clearance rates than vehicle with unproblematic safety and positive esthetic outcome.

PubMed ID

40846240

ePublication

ePub ahead of print

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