Safety and Efficacy of a Cohesive Polydensified Matrix Hyaluronic Acid for the Correction of Infraorbital Hollow: An Observational Study With Results at 40 Weeks

September 2014 | Volume 13 | Issue 9 | Original Article | 1030 | Copyright © September 2014


Oscar Hevia MD,a,b Bernard H. Cohen MD,b,c and David J. Howell PhDd

aHevia Cosmetic Dermatology, Coral Gables, FL
bUniversity of Miami in the Department of Dermatology and Cutaneous Surgery, Miami, FL
cPrivate practice, Coral Gables, FL
dSan Francisco, CA

Abstract
BACKGROUND: Utilizing a soft-tissue filler that is more fluid and less resistant to deformation may be advantageous for correction of infraorbital hollows.
OBJECTIVE: The objective of this study was to determine the safety and efficacy of the latest hyaluronic acid filler, created with a cohesive polydensified matrix, with a low elasticity and viscosity, for infraorbital hollows correction.
METHODS AND MATERIALS: Subjects (49) with at least a grade 2 Merz infraorbital hollow scale in the Validated Assessment Scales for the mid face (0-4) of the right and/or left side were photographed and treated at baseline, and with a touch up treatment after 2 weeks if necessary. Subjects were also photographed at 2, 6, and 10 months after baseline, with optional retreatment at 6 months. The photographs were graded by a blinded sub-investigator.
RESULTS: Mean hollowness scores for both eyes, either individually or combined, at 2, 6, and 10 months were considerably improved compared to baseline (P <.001). No serious adverse events were reported. Of the 46 subjects completing the study, 31 (66%) did not request retreatment after 6 months. At 10 months, 27/31 (87%) still exhibited a hollowness improvement of at least 1-point from baseline.
CONCLUSION: Belotero Balance was safe and effective for the correction of infraorbital hollows.

J Drugs Dermatol. 2014;13(9):1030-1036.

INTRODUCTION

Volume loss under the eyes results in a hollowed out appearance below the eyes. This appearance is referred to as “infraorbital hollows”. It may be caused by one or more of the following: (1) loss of infraorbital subcutaneous fat, (2) protrusion of infraorbital fat pads (“bags”), and (3) sagging of the upper cheek.1-4 These events, often the sequellae of normal aging processes, are more pronounced in some individuals than in others.
Correction of infraorbital hollows is an increasingly important nonsurgical procedure for the restoration of the aging face.5 In the clinical literature, studies of hyaluronic acid (HA) soft tissue fillers for treatment of infraorbital hollows have of late regularly appeared.5, 6-18 Several of these articles have addressed the use of primarily small particle HA, or Restylane, for infraorbital hollows and/or tear troughs,13,16,19 Juvéderm,20 and at least one reports on the use of Perlane.11 Other more recent publications speak broadly of HA fillers, including Belotero Balance.21-23 In 2013, a supplement on Belotero Balance was published in Plastic Surgery in which authors provided a detailed review of the clinical literature as well as a commentary on the application vis-à-vis other HAs.24,25
The ideal filler for this region of the face should be “malleable,” so that any uneven or raised areas can be smoothed out with gentle finger pressure immediately following injection. Belotero Balance® (Merz North America, Greensboro, NC), manufactured to create a cohesive polydensified matrix hyaluronic acid (CPMHA), was approved by the FDA in 2011 for the correction of moderate to severe nasolabial folds and wrinkles. Among the fillers currently available in the US, Belotero Balance exhibits the least stiffness (lowest G-prime value) and lowest resistance to deformation (or complex modulus value).26 The lowest stiffness is helpful for injection precision and the lowest resistance to deformation will help the filler conform to the injection-site contour as well as disperse uniformly with digital pressure or massage immediately following injection. These two properties help make it attractive for use in the infraorbital area, where any overcorrection or irregularity is readily apparent. In this paper, investigators report their findings in 46 patients on the use of Belotero Balance in the infraorbital region, with evaluations out to 40 weeks.

Study Objective

The objective of this study was to determine the safety and efficacy of Belotero Balance for the correction of infraorbital hollows.

Patient Population

Of the 49 patients enrolled, 46 (87.8%) completed the study. Of these patients, 38 were female and 8 were male. Age range of subjects was from 31 years to 67 years, with a mean age of 51 years.
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