The efficacy and adverse reactions of 755 nm picosecond alexandrite laser on the treatment of nevus of Ota at different endpoints: A split-lesion, single-blinded, randomized controlled comparison study.

Abstract

The picosecond alexandrite laser (PSAL) is a first-line treatment for nevus of Ota. However, low-fluence PSAL (LF-PSAL) that does not produce immediate whitening as treatment endpoint, remains unexplored. To compare the efficacy and safety of LF-PSAL versus conventional high fluence PSAL (HF-PSAL) for treating nevus of Ota. Each lesion of 64 participants (38 aged <5 years, 26 aged >5 years) with nevus of Ota was randomly split and assigned to receive either HF-PSAL or LF-PSAL. Each section underwent 3 treatment sessions at 6-month interval. Efficacy was assessed by blinded visual evaluation 12 months after the final treatment. All adverse events were documented. After 3 treatments, LF-PSAL achieved clearance scores comparable to HF-PSAL (4.54 ± 0.81 vs 4.59 ± 0.90, 95%CI -0.32 to 0.21, P = .68) with higher patient satisfaction among those aged <5 years. In participants aged >5 years, HF-PSAL yielded significantly higher clearance scores (4.46 ± 0.68 vs 4.00 ± 0.80, P < .05), with increased associated downtime and adverse events. Lack of objective assessments and outcome measures as well as sample size. In this study, LF-PSAL was noninferior to HF-PSAL in efficacy and results in minimal adverse events for patients aged < 5 years in the treatment of nevus of Ota.