A 12-Month, Prospective, Evaluator-Blinded Study of Small Gel Particle Hyaluronic Acid Filler in the Correction of Temporal Fossa Volume Loss

April 2013 | Volume 12 | Issue 4 | Journal Article | 470 | Copyright © April 2013


Amir Moradi MD,a Azadeh Shirazi MD,b and Jeanette Moradi CRCa

aMoradi MD, Vista, CA bScripps Dermatology and Cosmetic Surgery, La Jolla, CA

Abstract
OBJECTIVE: The primary objective of this study is to examine the use and persistency of small gel particle hyaluronic acid (SGP-HA) filler (Restylane®; Medicis Aesthetics Inc, Scottsdale, AZ) in the treatment of temporal fossa volumization over a 12-month follow-up, and determine local adverse events (AEs).
STUDY DESIGN: This is a US Food and Drug Administration-approved, blinded, prospective, single-center, open-label trial enrolling 20 subjects undergoing subcutaneous injection of SGP-HA for rejuvenation of the temples. Primary outcomes were measured using a standardized grading system—the Hollowness Severity Rating Scale (HSRS)—at each visit by the treating investigator, a blinded physician assessment of randomized photos using the HSRS, and patient questionnaires over a 12-month period. AEs were monitored by the investigator and via patient diaries.
RESULTS: At weeks 4, 12, and 24, and month 12, all graders (ie, investigator, blinded physician assessor, and patients) reported improvement overall in hollowness. At baseline, temporal fossa hollowness was measured as moderate to severe. At week 4 to month 12, temporal fossa was graded at none or only mild hollowness. No touch-ups were necessary at week 4 on all subjects. All AEs were mild or moderate and resolved within 2 weeks.
CONCLUSION: Our study demonstrates clinically significant efficacy and safety in the use of Restylane for temple augmentation and, thus, facial rejuventation.

J Drugs Dermatol. 2013;12(4):470-475.

INTRODUCTION

During the aging process, the temporal bone becomes more concave, the volume of the overlying temporalis muscle decreases, and the temporal fat pad diminishes in size.1 As a result of these changes, the youthful convex curve and fullness of the temporal region often disappears. Hollow temples contribute to the upper face appearing "pinched" and the brows appearing short and ptotic.2 Also, as the temple becomes more concave, the bony margins of the zygomatic arch and temporal line appear more prominent, giving a skeletonized appearance.3
Soft tissue augmentation with injectable dermal fillers has become a common treatment option for patients seeking rejuvenation of this region of the face. Augmentation of the temporal fossa has been accomplished using surgical alloplasts, autologous fat, and dermal fillers such as hyaluronic acid (HA),2-6 calcium hydroxylapatite,1,7 and poly-L-lactic acid.8
Dermal fillers have been used primarily in treating the nasolabial folds. In recent years, however, the aesthetic field has come to appreciate its value in treating the lateral face, including the temporal fossae, to obtain a more youthful appearance in the practice of facial rejuvenation.2-6 Although the temporal fossa is a critical area for volume restoration of the aging face, prospective, blinded studies are limited or nonexistent.

Study Design

This study was a prospective, blinded, single-center, open-label trial. The primary objective of this study was to examine the use of a small gel particle HA (SGP-HA) dermal filler (Restylane®; Medicis Aesthetics Inc, Scottsdale, AZ) in the treatment of temporal fossa volumization and determine local adverse events (AEs). Twenty subjects were enrolled in the study to undergo subcutaneous injection of the SGP-HA filler for rejuvenation of the temples. The study protocol was approved by the US Food and Drug Administration (FDA) and the Investigational Review Board before the start of the research. Investigational Device Exemption was granted by the FDA so that SGP-HA could be safely used in the temporal fossa.
The authors created a grading scale to provide a standardized method of determining the degree of hollowness. We have named the scale the Hollowness Severity Rating Scale (HSRS), and it is the first and only standardized scale to date (Table 1).
Individuals eligible for inclusion in this study included males or nonpregnant, non-breastfeeding females aged 18 to 65 years, including subjects seeking therapy for correction of temporal fossa volume loss who had temporal fossa volume HSRS scores of moderate (3) or severe (4) (Table 1); subjects with the ability to understand and comply with the requirements
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