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

September 2021 | Volume 20 | Issue 9 | Original Article | 949 | Copyright © September 2021


Published online August 30, 2021

Derek Jones MD,a Leslie Baumann MD,b Amir Moradi MD,c Sachin Shridharani MD,d Melanie Palm MD,e Craig Teller MD,f Mark Taylor MD,g Theda C. Kontis MD,h Anne Chapas MD,i Michael S. Kaminer MD,j David Bank MD,k Kenneth Beer MD,l Deirdre Hooper MDm

aSkin Care and Laser Physicians of Beverly Hills, West Hollywood, CA
bBaumann Cosmetic & Research Institute, Inc., Miami, FL
cMoradi, M.D., San Diego, CA
dLUXURGERY, New York, NY
eArt of Skin MD, Solana Beach, CA
fBellaire Dermatology Associates, Bellaire, TX
gGateway Aesthetic Institute and Laser Center/Advanced Clinical Research Inc., Salt Lake City, UT
hFacial Plastic Surgicenter, Ltd., Baltimore, MD
iUnion Square Laser Dermatology, New York, NY
jSkinCare Physicians, Chestnut Hill, MA
kThe Center for Dermatology, Cosmetic & Laser Surgery, Mt. Kisco, NY
lResearch Institute of SouthEast, LLC, West Palm Beach, FL
mAudubon Dermatology, New Orleans, LA

Abstract
Background: HARC is a soft and flexible hyaluronic acid filler containing lidocaine, manufactured using XpresHAn® technology, restoring natural-looking volume and soft contours.
Objectives: To evaluate safety and effectiveness of HARC for cheek augmentation and correction of midface contour deficiencies compared to a control product HAJV (hereafter referred to as Control). Primary objective was to demonstrate non-inferiority of HARC compared to the Control, by blinded evaluation of change from baseline in midface fullness 12 weeks after last injection, using a 4 grade midface volume scale (MMVS).
Materials and Methods: Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 2:1 to treatment with HARC(n=142) or Control (n=68). Optional touch-up was allowed after 4 weeks. Study assessments included MMVS, aesthetic improvement, subject satisfaction, and safety. Subjects were followed for 48 weeks.
Results: Overall, most subjects were female (89%) and mean age was 53 years (range 24-80). Total mean volume injected was 4.3 mL for HARC and 4.9 mL for Control. Primary objective was met; mean change from baseline in MMVS score at week 12: -1.4 (HARC), -1.3 (Control), 95% CI: -0.22, 0.06. HARC effectiveness was supported by a high degree of aesthetic improvement and subject satisfaction throughout 48 weeks. Related adverse events were generally mild and transient.
Conclusions: HARC was well tolerated and non-inferior to Control for correction of midface fullness at 12 weeks after last injection. Aesthetic improvement and subject satisfaction were high and lasted through week 48.  

J Drugs Dermatol. 2021;20(9):949-956. doi:10.36849/JDD.6191

INTRODUCTION

Volume loss resulting in descent of midfacial soft tissues is a main factor for facial age-related changes. Dermal fillers are frequently used to address such losses by replenishing midface volume.1,2 The Restylane® range of products are each designed to have optimal gel properties for their indication, by varying the degree of firmness (G’) and flexibility (xStrain) for specific patient needs.3 Restylane Contour (hereafter HARC) is a soft and flexible lidocaine-containing gel with high lifting capacity. It is manufactured using the XpresHAn® technology (OBT™ in the EU) that creates smooth gels with features that are characterized by varying degrees of cross-linking, which allows for volume and tissue integration, restoring natural expressions in dynamic areas and soft contours.4-7
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