Complete Remission of Superficial Basal Cell Carcinoma Using Automatic Patting System‐Assisted Topical 5‐Fluorouracil Therapy: Preliminary Clinical Evidence

ABSTRACT Background Topical 5‐fluorouracil (5‐FU) is a validated non‐invasive treatment for superficial basal cell carcinoma (sBCC), but its effectiveness may be limited by suboptimal skin penetration and local toxicity. Objectives To evaluate a galenic 5‐FU formulation delivered with Automatic Patting System (APS)‐assisted transdermal enhancement in patients with sBCC. Methods We conducted a prospective observational study including six patients with nine clinically, dermoscopically, and Line‐Field Confocal Optical Coherence Tomography (LC‐OCT)‐diagnosed sBCCs. Lesions were treated once weekly for 4 to 7 weeks using APS protocols combining Skin Patting and iontophoresis, with treatment intensity adapted by anatomical site. The galenic preparation consisted of a liposomal 5‐FU gel. Preclinical support came from ex vivo permeation studies on dermatomed pig ear skin mounted on Franz diffusion cells, assessing 5‐FU permeation and retention after APS‐assisted delivery. Results Treatment was well tolerated, with only mild expected procedural bleeding. Five of nine lesions achieved complete response, confirmed clinically and by LC‐OCT when follow‐up imaging was available, whereas four lesions showed partial response. Complete remission occurred 7 to 11 weeks after treatment initiation, with no recurrence observed during follow‐up of up to 9 months in lesions achieving complete response. Ex vivo studies showed significantly greater 5‐FU permeation with APS‐assisted treatment than with passive application at 5 h, together with increased drug retention within the skin membrane and greater delivery with extended treatment protocols. Limitations The small sample size, absence of a control group, and relatively short follow‐up limit the generalizability of these findings. Conclusions In this preliminary series, five of nine sBCCs achieved complete response following APS‐assisted topical 5‐FU, while four showed partial response. These findings are descriptive and require confirmation in larger controlled studies.