The additive efficacy of therapeutic low-intensity pulsed ultrasound in the treatment of vitiligo: A randomized, left-right comparison clinical trial

Repigmentation of vitiligo relies on the proliferation and migration of melanoblasts from hair follicles to the epidermis to replenish epidermal melanin. Our previous study has demonstrated low-intensity pulsed ultrasound (LIPUS) can stimulate melanoblast migration in vitro. We sought to evaluate the potential additive efficacy and safety of LIPUS for repigmentation of vitiligo. Twenty-seven adult patients with stable generalized vitiligo on the face or trunk were recruited in this randomized, open, left-right comparison study. In each patient, two symmetric lesional sites were randomly selected; one was assigned as the target lesion, which was treated with add-on LIPUS twice weekly for 24 weeks, and the other as the control lesion, which was administrated with sham sonification. The primary outcome was the difference of repigmentation degree between the target and control lesions at week 24, based on the 7-point physician global assessment score. At the end of study, 23 patients with vitiligo on the face (n = 10) or trunk (n = 13) completed the 24-week treatment course. Enhanced repigmentation for vitiligo receiving LIPUS as compared to sham sonification was observed in 38.5% (5/13) of the patients with truncal vitiligo, but none of those with facial vitiligo. Truncal vitiligo (P = .046) and higher intensity of LIPUS administered (P = .01) were statistically significantly associated with the effectiveness of additive LIPUS treatment. The LIPUS treatment was well-tolerated without remarkable adverse effects. This pilot study showed that LIPUS could provide therapeutic benefits and could be considered as a treatment adjunct for truncal vitiligo.