Clinical safety and tolerability of repeated high-fluence 405 nm blue light exposure in chronic wounds.

In 30 seconds

This phase I clinical trial evaluated the safety and tolerability of repeated high-fluence 405 nm blue light exposure in 22 patients with chronic wounds. Over four weeks, patients received blue light at 20, 60, or 100 J/cm² three times weekly. Most patients experienced only mild reactions, with one developing a Grade 2 blister. No serious adverse events occurred.

Key findings

• All but one patient showed Grade 1 CTCAE Skin Domain reactions during the study.
• 28 adverse events were reported, all deemed unrelated to treatment.
• Pain levels were predominantly absent or mild, with no significant differences across dose groups.
• No negative impact on wound healing was observed, with p > 0.05.

Why it matters

Understanding the safety profile of high-fluence blue light therapy is crucial for clinicians considering new treatments for chronic wounds. This study suggests that such therapy may be safely integrated into patient care without significant adverse effects.