Jet‐injection assisted photodynamic therapy for superficial and nodular basal cell carcinoma: A pilot study

Background Photodynamic therapy (PDT) with topical δ‐Aminolevulinic acid (ALA) has efficacy in treating basal cell carcinoma (BCC) but is limited by incomplete penetration of ALA into the deeper dermis. This prospective open‐label pilot trial investigated the safety and efficacy of photosensitizer jet injection for PDT (JI‐PDT) for BCC treatment. It was performed with 15 patients (n = 15) with histologically confirmed, untreated, low‐risk nodular BCCs at a single institution. Methods For the intervention, JI‐PDT patients (n = 11) received two sessions of jet‐injected ALA with PDT separated by four to 6 weeks. To further understand treatment technique, another group of patients (n = 4) received jet‐injected ALA followed by tumor excision and fluorescence microscopy (JI‐E). Treatment tolerability was assessed by local skin responses (LSR) score at five distinct time intervals. Fluorescence microscopy assessed protoporphyrin IX penetration depth and biodistribution within the tumor. At the primary endpoint, tumor clearance was evaluated via visual inspection, dermoscopy and reflectance confocal microscopy. Postinjection and postillumination pain levels, and patient satisfaction, were scored on a 0−10 scale. Results Fifteen participants with mean age of 58.3, who were 15/15 White, non‐Hispanic enrolled. The median composite LSR score immediately after JI‐PDT was 5 (interquartile range [IQR] = 3) which decreased to 0.5 (IQR = 1) at primary endpoint (p