Increased Tattoo Fading in a Single Laser Tattoo Removal Session Enabled by a Rapid Acoustic Pulse Device: A Prospective Clinical Trial

Background and Objectives The ability to provide improved tattoo fading using multiple laser passes in a single office laser tattoo removal session is limited. In part, this is due to the loss of laser effectiveness caused by epidermal and dermal vacuole "whitening" generated during the initial laser pass at the tattoo site. The Rapid Acoustic Pulse (RAP) device generates acoustic shock wave pulses that clear epidermal and dermal vacuoles to enable multiple laser passes in a single office laser tattoo removal session. The objectives of this study were to determine if the RAP device, when used as an accessory to the 1064 nm Nd:YAG Q-switched (QS) laser can enable delivery of multiple laser passes in a single office laser tattoo removal session, and therefore result in increased tattoo fading compared to the clinical standard single-pass QS laser tattoo removal session. Study Design/Materials and Methods The RAP device was evaluated in a single-center (SkinCare Physicians), prospective, IRB approved study. A total of 32 black ink tattoos, from 21 participants, were divided into three zones and treated with either multiple QS laser passes, each followed by 1 minute of RAP device application (Laser + RAP) in zone one and single-pass QS laser treatment (Laser-Only) in zone two, separated by an untreated control zone. The treatment sites were assessed for the number of laser passes and adverse events immediately, 6 weeks, and 12 weeks following the treatment session. Photographs of the treatment sites were assessed for percent fading at 12 weeks post-treatment by three blinded reviewers. Results When the RAP device was applied as an accessory to the QS laser in a multi-pass laser tattoo removal treatment, an average of 4.2 laser passes were delivered in a single session, with no unexpected or serious RAP device-related adverse events. At the 12-week follow-up, tattoos treated with Laser + RAP showed a statistically significant increase in average fading (44.2%) compared with tattoos treated with Laser-Only (24.8%) (P < 0.01). Additionally, a significantly higher overall proportion of tattoos treated with Laser + RAP (37.5%) had a response of >50% fading compared with tattoos treated with QS Laser-Only (9.4%) (P < 0.01) as well as a response of >75% fading from Laser + RAP treatment (21.9%) compared with Laser-Only treatment (3.1%) (P < 0.05). Conclusions The RAP device, applied as an accessory to the 1064 nm Nd:YAG QS laser, safely enables multiple QS laser treatments in a single office laser tattoo removal session by clearing the whitening caused by the previous QS laser pass. Enabling multiple QS laser passes results in a statistically significant increase in tattoo fading in a single office laser tattoo removal session compared to the clinical standard single-pass QS laser tattoo removal session. (c) 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.