A Randomized, Evaluator-Blinded, Comparator-Controlled, Study to Evaluate Safety and Effectiveness of Harc for Cheek Augmentation and Correction of Midface Contour Deficiencies

Shridharani, Sachin M.

A Randomized, Evaluator-Blinded, Comparator-Controlled, Study to Evaluate Safety and Effectiveness of Harc for Cheek Augmentation and Correction of Midface Contour Deficiencies

Sachin M. Shridharani, MD, LUXURGERY, New York, NY, Derek H. Jones, MD, Private Practice, Los Angeles, CA, Leslie Baumann, MD, Baumann Cosmetic & Research Institute, Inc., Miami, FL, Amir Moradi, MD, MBA, Private Practice, Vista, CA, Melanie Palm, MD, MBA, 5Art of Skin MD, Solana Beach, CA, Craig Teller, MD, Bellaire Dermatology Associates, Bellaire, TX, Mark Taylor, MD, Gateway Aesthetic Institute and Laser Center/Advanced Clinical Research Inc., Salt Lake City, UT, Theda Kontis, MD, Facial Plastic Surgicenter, Ltd., Baltimore, MD, Anne Chapas, MD, Union Square Laser Dermatology, New York, NY, Michael Kaminer, MD, SkinCare Physicians, Chestnut Hill, MA, David Bank, MD, FAAD, The Center for Dermatology cosmetic & Laser Surgery, Mt Kisco, NY, Kenneth Beer, MD, Research Institute of SouthEast, LLC, West Palm Beach, FL and Deirdre Hooper, MD, Audubon Dermatology, New Orleans, LA

Goals/Purpose
:

To evaluate safety and effectiveness of HA_RC for cheek augmentation and correction of midface contour deficiencies.

Methods/Technique

In this randomized, evaluator-blinded, comparator-controlled study, subjects with loss of fullness in the midface area were randomized 2:1 to treatment (≤6 mL) with HA_RC or comparator (HA_JVOL). Optional touch-up (≤6 mL) was allowed after 4 weeks. The primary objective was to demonstrate non-inferiority of HA_RC relative to comparator in change from baseline on a 4‑grade midface volume scale¹ (MMVS), 12 weeks after last injection. Secondary objectives included aesthetic improvement, improvement in cheek augmentation (independent photographic reviewer), subject satisfaction, and safety.

Results/Complications

Subjects were randomized to treatment with HA_RC (n=142) or comparator (n=68). Most subjects were female (89%) and overall mean age was 53 years (range 24-80). Total mean volume injected was statistically less for HA_RC than comparator (4.3 mL and 4.9 mL, respectively, p=0.0134). The primary objective was met as HA_RC was non-inferior to comparator in midface fullness at 12 weeks after last injection (mean change from baseline in MMVS score: -1.4 [HA_RC], -1.3 [comparator]). HA_RC effectiveness was supported by a high degree of aesthetic improvement (≥77%) and subject satisfaction throughout the study. Cheek augmentation was assessed as improved for ≥65% of HA_RC subjects at week 48. Treatments were well tolerated; related adverse events were generally mild and transient.

Conclusion

HA_RC was effective, well-tolerated, and non-inferior to comparator for cheek augmentation and correction of midface contour deficiencies. Subjects treated with HA_RC required less total volume injected to achieve optimal aesthetic results.

Reference

1. Lorenc ZP, Bank D, Kane M, Lin X, Smith S. Validation of a four-point photographic scale for the assessment of midface volume loss and/or contour deficiency. Plastic and reconstructive surgery. 2012;130(6):1330-1336.