A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour Deficiencies

HA_RC: 93%, Control: 91%. There was one event of severe implant site swelling in the Control group that resolved with no action taken, duration was 3 days. Median duration of related adverse events in Group A was 3 days for both HARC and Control. The most commonly reported related adverse events following treatment with HA_RC was pain (6 subjects [4.3%]) and bruising (5 subjects [3.5%]). The most reported related adverse events for both HA_RC and Control is displayed in Table 2.

In Group B, only 2 subjects (3.4%) experienced 1 related adverse event each (presyncope and catheter site erythema), both were mild.

This was a randomized, comparator-controlled, evaluatorblinded, multi-center study to evaluate the effectiveness and safety of HA_RC for cheek augmentation and correction of midface contour deficiencies (Group A); the study also evaluated HA_RC when injected by cannula vs. needle (Group B). This was the first HA_RC study conducted in the US, and subjects from all Fitzpatrick skin types were included. Subjects who were rated as MMVS grade 2–4 (mild to severe midface volume loss) at baseline were injected per their randomized allocation. In Group A, HA_RC subjects required less injected product than Control subjects to achieve optimal aesthetic results. Injection with needle and cannula in Group B required very similar volume of HA_RC.

The study met its primary objective demonstrating noninferiority between HA_RC and Control, assessed by a blinded evaluator. In addition, a majority of subjects injected with HA_RC, both from Group A and B, achieved a 1-grade or greater MMVS improvement from baseline at all study timepoints until Week 48. The effectiveness of HA_RC was further supported by high levels of aesthetic improvement based on GAIS, as assessed by subjects themselves and by treating investigators, and many Group A and Group B subjects reported satisfaction with their cheeks and with treatment outcome from FACE-Q scores. It was also visible from blinded pairings of baseline and posttreatment photographs that most subjects had improvement in cheek augmentation by independent photographic review.

Quantification of cheek volume enhancement after HA_RC treatment was also confirmed by 3D photography; the largest change from baseline was 3.3 mL and decreased thereafter as the product degraded.

Treatment with HA_RC was well tolerated and fewer subjects reported related adverse events than in the Control group. Also, only 3% of Group B subjects reported related adverse events. HA_RC has previously been studied for full-face correction of volume loss in an open-label study with 18 months follow-up.⁹ In that study, more than two thirds of subjects were improved from baseline at study end and the treatment was well tolerated with no significant safety concerns. HA_RC has also been investigated in another open-label study to assess performance and tolerance of the product in patients with cheek volume loss.¹⁰ The results showed a majority of subjects with maintained cheek volume up to six months after treatment.

Injection technique is in many cases based on the injector’s preference and experience, and the data from Group B in this study where subjects were injected using a split-face design with one cheek treated using cannula and the other cheek using needle, showed comparable effectiveness between injection tools and an overall good safety profile. Cannula injections have been reported to result in reduced bruising compared to needle,^12,13 this could not be confirmed in this study as no bruising was reported for either injection tool in Group B. Midface treatment using a small blunt-tip cannula with another filler from the Restylane range of products, Restylane Lyft, has previously been investigated and shown to be well tolerated for cheek augmentation and correction of age-related midface contour deficiency, and with visible aesthetic improvement.¹⁴

In conclusion, HA_RC was non-inferior to Control for correction of midface fullness at 12 weeks after last injection. This study also showed that midfacial treatment using HA_RC was well tolerated and effective, with high levels of aesthetic improvement and subject satisfaction for up to 48 weeks.

Dr Jones is an investigator for Galderma, Allergan, Merz, and Revance; Dr Baumann is an investigator for Galderma; Dr Moradi is an investigator and consultant for Galderma; Dr Shridharani is an investigator and consultant for Allergan, Endo, Evolus, Galderma, and Prollenium; Dr Palm is an investigator, speaker, paid advisory board member, and consultant for Galderma; Dr Teller is an investigator for Galerma; Dr Taylor is an investigator for Galderma; Dr Kontis is an investigator for Galderma, Revance, and Allergan and a consultant for Revance; Dr Chapas is an investigator for Galderma and received research grant from Galderma R&D, LLC; Dr Kaminer is an investigator for Galderma and a consultant for L’Oreal, Revance, Allergan, Arctic Fox, and Soliton; Dr Bank is an investigator and speaker for Galderma, Allergan, Evolus, Johnson & Johnson, and Merz, and a consultant for Allergan, Johnson & Johnson, Croma Pharma, Merz, Galderma, and Evolus; Dr Beer is an investigator for Galderma; Dr Hooper is an investigator, speaker, paid advisory board member, and consultant for Galderma.

Galderma funded the study and provided medical writing support.

The authors would like to thank Benjamin Bassichis MD;