RESUMEN
Background: Nano-Pulse Stimulation™ (NPS™) therapy is a new, non-thermal bioelectric modality that applies ultrashort pulses of electric energy to trigger regulated cell death (RCD) in treated tissues. Instead of initiating necrosis by heating or freezing, NPS therapy permeabilizes intracellular organelles to activate the cell's own self-destruct pathway of programmed or regulated cell death. Unlike cryotherapeutic procedures that can both damage structural tissues and diffuse into the periphery beyond the margins of the lesion, NPS therapy only affects cells within the treated zone leaving surrounding tissue and acellular components unaffected. Methods: In this study we treated 37 basal cell carcinoma lesions on 30 subjects (NCT04918381). The treated lesions were photographed on 3-, 7-, 14-, 30- and 60-days after treatment. All subjects then underwent surgical excision for histological examination of the treated tissue. Results: 92% of the BCC lesions (34 of 37) showed complete histological clearance of BCC. Histologic analysis of the 3 cases where residual BCC was noted indicated that full energy coverage was not achieved, which could be remedied with an improved treatment guide to standardize and optimize the CellFX® procedure based on NPS technology. Conclusion: The CellFX procedure was shown to be safe and effective for the treatment of low-risk nodular and superficial BCC lesions.
RESUMEN
Artificial white LED light photodynamic therapy (awl-PDT) is an effective, pain-free treatment for actinic keratosis. The efficacy of awl-PDT in the treatment of superficial basal cell carcinoma (sBCC) has not been assessed. Patients with histologically confirmed sBCC underwent two treatments of awl-PDT 1 week apart. Lesions were incubated with methyl 5-aminolaevulinic acid for 30 min and then illuminated using the Maquet Power LED 500 theatre light (405-800nm, 140 000 lux) to deliver an equivalent red light dose of 75 J/cm2 at a rate of 55 mW/cm2 . Pain was measured using a visual analogue scale during treatment. Clinical response was assessed at day 28. Follow-up continued 3 months for 1 year. Cosmetic outcome was assessed at 3 months and 1 year. Twenty-eight patients with 36 lesions and a mean age of 63.64 (SD 2.62) were recruited. The median lesion size was 15 mm (IQR 8.75). The response rate at day 28 was 100%. Recurrence rates were 3/36 (8.3%) at 3 months, 6/36 (16.7%) at 6 months, 10/36 (27.8%) at 9 months and 11/36 (30.6%) at 1 year. Median pain scores were 0/100 (IQR 0) and 0/100 (IQR 5) during treatments one and two, respectively. Cosmetic outcome was excellent or good in the majority of cases. Although initially effective for sBCC at 28 days, 30.6% of lesions recurred 1 year after awl-PDT. Pain scores were negligible, and the cosmetic outcome was favourable. Further head-to-head studies with optimised protocols are required to determine if awl-PDT has a role in the treatment of sBCC.