tenderness (99% of subjects), pain (97%), and swelling (95%; Figure 5). Most subjects reported these events as tolerable and as resolved within 1-2 weeks. A similar profile of post-injection events was reported after the touch-up injection (Figure 5).
In total, 24 subjects (19%) treated with HASHA experienced a product- or injection-related AE, 80% of which were mild or moderate in intensity. The most common product- or injection-related AEs (>2.0% of subjects) were implant site mass (5.5%), implant site pain (4.7%), implant site nodule (3.9%), and headache (3.1%). Implant site pain generally started on the day of injection and had a median duration of 2.0 days. There were 13 events of implant site mass (n=8) and nodules (n=5). Of these, no events of mass and 4 nodules were delayed (starting >21 days after treatment). Two events of nodule were inflammatory, and one of these had delayed onset. There were no product- or injection-related serious AEs reported. No subjects experienced a change in chin hair growth during the study.
Post hoc analyses of product- or injection-related AEs based on injected volume (greater than or less than/equal to 2.8 mL, the median volume) showed that a larger proportion of subjects had AEs related to the product --- including implant site nodules and mass --- after injection with >2.8 mL (Table 3).
DISCUSSION
The results of this study demonstrate that HASHA significantly improves chin retrusion from baseline, compared with a no-treatment control. Notably, the GCRS response (Figure 1) was maintained in the majority of subjects, with a significant difference between the two groups for up to 12 months after the initial injection (with a touch-up at month 1). The long-term improvement in chin retrusion with HASHA treatment is supported by the GAIS results, which showed a high proportion of individuals (97% investigator assessment, and 91% subject assessment, Figure 2) with aesthetic improvement that was maintained at month 12. Even though not directly comparative, other pivotal studies evaluating chin augmentation with HA-based fillers, eg, using VYC-20L (Juvederm VolumaXC, Allergan) have shown GAIS aesthetic improvement rates for chin augmentation at month 12 of 91%/82% according to investigators/subjects.7 In a pivotal study of VYC-25L (Juvederm Volux, Allergan) GAIS responder rates in the treatment of chin retrusion were 84%/77% at month 12 according to investigators/subjects, respectively.
HASHA had an overall acceptable safety profile in relation to the positive results of treatment reported by the subjects, eg, high satisfaction and GAIS results (Figures 2 and 3). Subject-reported, predefined, expected injection-related events (pain, tenderness, redness, bruising, swelling, and itching, Figure 5) in the 4-week diaries were mostly tolerable and transient, usually resolving within 1-2 weeks. Most product- or injection-related AEs reported by the investigators were mild or moderate in intensity and there were no
HASHA had an overall acceptable safety profile in relation to the positive results of treatment reported by the subjects, eg, high satisfaction and GAIS results (Figures 2 and 3). Subject-reported, predefined, expected injection-related events (pain, tenderness, redness, bruising, swelling, and itching, Figure 5) in the 4-week diaries were mostly tolerable and transient, usually resolving within 1-2 weeks. Most product- or injection-related AEs reported by the investigators were mild or moderate in intensity and there were no
