Double-Blind, Randomized, Controlled Split-Face Trial to Assess the Efficacy and Safety of a Liposomal Lidocaine Topical for Pain Management During Micro-Focused Ultrasound Treatment

Goals/Purpose: The primary purpose of this study was to assess the safety and level of pain control provided by commercially available liposomal lidocaine topical compared to control used prior to micro-focused ultrasound (MFU) treatments.   Efficacy of the MFU treatment will also be , secondarily, to ensure the topical has no effect on treatment outcomes.

Methods/Technique: N=15.  Liposomal lidocaine topical (active) and a control cream (of similar consistency and color) was applied in a split-face design and in random order to right and left sides of the face.   Treating investigators and subjects were blinded to which side was treated with active.  All patients were also given 800mg of Ibuprofen 60 minutes prior to MFU treatments.  30 minutes after application of topical and control cream, one side of the face was washed, wiped with alcohol to remove residual tackiness, and treated with MFU per guidelines.  The same steps were then completed on the other side.  Subjects were asked to report an average Numeric Rating Scale (NRS) pain scores for each facial region immediately after treatment and for each depth treated (3.0mm or 4.5mm).   Efficacy based on masked-observer ratings will be assessed at 90 and 180 days.   Safety, based on AE incidence, was also assessed.

Results/Complications: At this interim time point, for active/control (presented in this order) average scores were 4.8 ± 2.3/5.5 ± 2.5 (peri-orbital), 4.1 ± 2.6/4.6 ± 2.0 (cheek),  and 3.8 ± 1.9/4.1 ± 2.4 (submandibular), for the 3.0mm depth and 5.7 ± 2.3/6.0 ± 2.5 (peri-orbital), 4.6 ± 2.2/4.9 ± 2.4 (cheek),  and 2.7 ± 1.8/3.5 ± 1.7 (submandibular) for the 4.5mm depth.  Combined average pain scores for all regions of the face were 3.8 ± 1.9 and 4.1 ± 2.4, for active and placebo control, respectively.  The incidence of AEs did not differ between sides treated with active versus control.

Conclusion: Liposomal lidocaine topical pre-treatment did not result in significant differences between facial region or combined pain scores when compared to control.   There was no significant difference in adverse events at this interim time point.   In these subjects who were administered 800mg of ibuprofen as a pre-treatment to micro-focused ultrasound procedures, average pain scores were <5 on a 10 point scale.  This finding is promising and suggests a single high dose of ibuprofen may be an effective means of pain control during MFU treatment.   NOTE:  Complete pain data and efficacy data at 90 days will be available at the time of presentation.