The Suitability of a Large Particle Hyaluronic Acid Filler for the Treatment of Temporal Hollowing

Supplemental Digital Content is Available in the Text. BACKGROUNDHyaluronic acid (HA) fillers may be manufactured to have distinctive physical properties that optimize their use for specific indications. Fillers manufactured with large gel calibration (particle size; HA-V) may be particularly suitable for volumizing large surface areas such as the temporal hollows.OBJECTIVETo investigate the safety and effectiveness of HA-V for the treatment of temporal hollows.MATERIALS AND METHODSA prospective, open-label, single-cohort, clinical trial was conducted. Twenty-six women who presented with bilateral temporal hollows at baseline were recruited. All subjects received treatment with HA-V and were observed at 4 to 5 in-person visits over 16 weeks. Subjective and objective measures of safety and efficacy parameters were collected through 2- and 3-dimensional imagery, questionnaires/scales (i.e., subject satisfaction, global aesthetic improvement, temporal hollowing severity), and adverse event diaries.RESULTSTo achieve optimal correction, the investigator used an average of 1.70 syringes per subject, per side. All treatments were performed using a bolus injection technique to place the product on the periosteum (bone) of the temporal region. Following optimal correction, all subjects (100%) displayed improvement in their global aesthetic appearance, and 25 of 26 subjects (96.15%) displayed >= 1 grade improvement on the temporal volume scale. Subject satisfaction was high, with 91.3% of subjects being satisfied with the appearance of their temporal regions following optimal correction.CONCLUSIONIn this pivotal trial, HA-V was evidenced to have an excellent safety profile and proven efficacy up to 16 weeks, making it a suitable HA filler for volumization of the temporal region.