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

[BACKGROUND] Hyaluronic 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.

[OBJECTIVE] To investigate the safety and effectiveness of HA-V for the treatment of temporal hollows.

[MATERIALS AND METHODS] A 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.

[RESULTS] To 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.

[CONCLUSION] In 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.