Table 2.
Summary of the adverse events in the HF-LED-RL and mock therapy groups in the MTD cohorts.
| STARS 1 (320 J/cm2) | STARS 2 (480 J/cm2) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse event | HF-LED-RL (n = 30) | Mock (n = 20) | P-value | HF-LED-RL (n = 30) | Mock (n = 20) | P-value | ||||
| n | % | n | % | n | % | n | % | |||
| Any erythema | 0.002 | 1.000 | ||||||||
| + | 28 | 93.3 | 10 | 50.0 | 30 | 100.0 | 20 | 100.0 | ||
| − | 2 | 6.7 | 10 | 50.0 | 0 | 0.0 | 0 | 0 | ||
| Erythema lasting more than 24 hours | 1.000 | 0.075 | ||||||||
| + | 1 | 3.3 | 0 | 0.0 | 5 | 16.7 | 0 | 0.0 | ||
| − | 29 | 96.7 | 20 | 100.0 | 25 | 83.3 | 20 | 100.0 | ||
| Hyperpigmentation | 0.003 | 0.002 | ||||||||
| + | 10 | 33.3 | 0 | 0.0 | 11 | 36.7 | 0 | 0.0 | ||
| − | 20 | 66.7 | 20 | 100.0 | 19 | 63.3 | 20 | 100.0 | ||
All P-values were determined using Fisher’s exact test. P-values ≤ 0.05 were considered statistically significant.
(+): present; (−): absent; HF-LED-RL: high fluence light-emitting diode-red light; MTD: maximum tolerated dose