35320 Pilot evaluation of safety and efficacy in diverse skin types of a novel topical hyaluronidase-polysaccharide formulation for contour irregularities following filler injection

Abstract

Injectable hyaluronidase is used off-label for skin contour irregularities, nodules or ischemia following hyaluronic acid (HA) fillers, and sometimes for non-HA filler nodules. However, hyaluronidase injections are associated with local allergic reactions (incidence 0.05-0.69% rising to 31.3% with 200,000 IU) and rare urticaria and angioedema (incidence < 0.1%). Availability and use of injectable hyaluronidase are limited by country-specific regulations, Some patients decline injections to address filler complications. After ethical board approval, 17 females aged 23 to 54 (six having skin phototypes IV-VI) with chronic post-filler contour irregularities received 1 to 3 topical treatments with a new formulation of hyaluronidase enzymatically complexed with botanical polysaccharides. Treated areas were infraorbital (10), lips (5), and malar festoons (2). Post-application massage was performed in office and at home. Two to 4 weeks after final treatment, physician-assessed contour improvement was 8-10/10 for 7 patients, 5-7/10 for 6, 1-4/10 for 3, and 0/10 for 1 patient. Fifteen patients evaluated their skin as more uniform (5/10 to 10/10). Satisfaction scores were 7-10/10 for 13 patients, 6/10 for 2, and 0-1/10 for 2. All evaluated treatment as Comfortable to Extremely Comfortable. The topical hyaluronidase-polysaccharide formulation has regulatory classification as a cosmetic. Based on this pilot evaluation, it may be of value in countries that prohibit injectable hyaluronidase, and for patients who decline injections. Larger, controlled studies will raise the evidence level for safety, efficacy and tolerability. It may be appropriate to evaluate nonaesthetic applications including granulomatous foreign body reactions and adjunctive acceleration of subcutaneous drug absorption and dispersion.