A Novel Topical Perfluorodecalin Gel for the Management of Radiotherapy-induced Skin Toxicity: A Prospective Observational Study

Background: Radiotherapy-induced skin toxicity, or radiation dermatitis (RD), is a common side effect of cancer treatment. RD ranges from mild erythema to severe desquamation and ulceration, significantly impairing patients’ quality of life. RD typically heals naturally within 2–4 weeks, but it can cause pain, distress, and interruptions of cancer therapy. Despite various topical treatments, an effective, universally applicable solution remains lacking. Objectives: This single-arm prospective observational pilot study aims to evaluate the feasibility, safety, and time trend of RD resolution with a novel silicone-based perfluorodecalin (PFD) gel, and to explore its effectiveness broad applicability across diverse patient characteristics as a foundation for future randomized trials. Methodology: Twenty-seven patients with breast or head-and-neck cancers and Radiation Therapy Oncology Group (RTOG) grade 2–3 dermatitis were enrolled within 48 h of completing radiotherapy. All patients applied PFD gel twice daily for 3 weeks. Skin toxicity was graded at baseline, week 1, week 2, and week 3 using the RTOG scale. Adverse events were monitored. Results: Statistical analysis demonstrated a significant reduction in RTOG grades over time ( P < 0.001), indicating progressive skin recovery. Subgroup analyses confirmed the gel’s efficacy irrespective of patient characteristics. Interaction effects between time points and these variables were nonsignificant, supporting the gel’s broad applicability. Conclusion: The gel effectively reduces radiation-induced skin toxicity and accelerates healing, independent of patient-specific factors. Its performance suggests potential integration into clinical practice to enhance patient comfort and treatment adherence. Further studies with larger samples are warranted to confirm these findings and expand their clinical application.