An observational-phase clinical trial for intralesional radiofrequency ablation in the treatment of slow-flow vascular malformations

Objectives: Current treatments for vascular malformations, such as sclerotherapy, laser ablation, and surgery, often result in suboptimal outcomes with high recurrence rates. This study aimed to evaluate intralesional radiofrequency ablation (RFA) as a potential treatment for slow-flow vascular malformations.The objective is to assess the efficacy and safety of intralesional RFA in treating slow-flow vascular malformations. Material and Methods: In this self-controlled observational study, 28 patients (ages 6–54) with slow-flow vascular malformations underwent two intralesional RFA sessions, spaced 4 weeks apart. An initial 16-week observational period served as the control phase. Outcomes included lesion volume (measured by ultrasound and clinical evaluation), Visual Analog Scale (VAS), dermatology life quality index (DLQI), patient satisfaction, and physician assessment. Results: Post-RFA, lesion volume decreased by 48.84% clinically and 25.99% by ultrasound, contrasting with volume increases of 6.02% and 10.04% during the control phase ( P < 0.01). VAS scores dropped from 7.71 to 3.96, and DLQI from 13.89 to 7.75 ( P < 0.001). Patient satisfaction was favorable (median score of 6), with mild transient adverse effects. Conclusion: Intralesional RFA significantly reduced lesion volume and improved patient-reported outcomes compared to the control phase.