Open Label Study Evaluating Efficacy, Safety, and Effects on Perception of Age After Injectable 20 mg/mL Hyaluronic Acid Gel for Volumization of Facial Temples

January 2019 | Volume 18 | Issue 1 | Original Article | 64 | Copyright © January 2019

Leslie S. Baumann MD FAAD,a Edmund M. Weisberg MS MBE,b Melissa Mayans,a Erika Arcuria

aBaumann Cosmetic and Research Institute, Miami, FL bJohns Hopkins Medicine, Baltimore, MD

Abstract
OBJECTIVE : To study the safety, efficacy, optimal volume, and longevity of an injectable hyaluronic acid (HA) gel dermal filler to treat facial temporal fossa fat loss. METHODS AND MATERIALS: This open-label, single-site, 12-month study used 20 mg/mL HA gel to correct volume loss in both temples in 30 subjects. Touch-ups were allowed at week 2. At each visit, the investigator completed a Frontal Temporal Fossa Scale and a 7-point satisfaction scale. Subjects completed a 7-point satisfaction scale, Subject Global Aesthetic Improvement Scale (GAIS), and self-perception of age assessment. Photos were taken at each visit. RESULTS: Subjects who returned for the one-month visit (29) achieved a ≥ 1-point improvement on the Temporal Fossa Scale in both temples. At month 12, 98% of the temples maintained a ≥ 1-grade, 18% showed a 3-grade, 34% showed a 2-grade, and 46% showed a 1-grade improvement. All subjects received an average of 1.1 mL per temple. Mild to moderate jaw pain after injections was noted by 40% of patients. The pain was reported to occur during mastication. There was no correlation between the amount of the study device injected and the incidence of jaw pain, which did not occur at the touch-up injections and was self-limited. Injections were well tolerated, and no patients developed vascular compromise, vascular events, or visual disturbances. CONCLUSION: HA gel (20 mg/mL) is safe and efficacious when used in the facial temporal fossa. The results lasted at least 12 months in 98% of subjects. Most subjects perceived themselves as looking younger than at baseline. J Drugs Dermatol. 2019;18(1):67-74.

INTRODUCTION

Volume deficit in the temporal fossa of the face (the lateral sides of the forehead) is a common sign of aging. Loss of fat in the temporal fossa can occur in younger people as well, especially those with a body fat percentage less than 20%. The loss of fat in the temple area can make people look older than their chronological age. Juve?derm Voluma XC (Allergan, Inc.) is a biodegradable gel im- plant composed of 20 mg/mL hyaluronic acid (HA) formulation, crosslinked and combined with 0.3 w/w lidocaine. This dermal filler is indicated for soft tissue augmentation using subcutaneous and/or supraperiosteal injection.This 20 mg/mL HA gel was approved by the FDA in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area. The use of this 20 mg/mL HA gel in the temple areas has not been approved by the FDA. Temples have been treated with various filler substances including fat,1 HA,2 and polylactic acid for over a decade.3 There have been several safety concerns about injection in the temple due to its proximity to the ophthalmic artery, the obstruction of which could lead to blindness. Moradi et al. conducted a study evaluating a NASHA HA-containing dermal filler known commercially as Restylane® for use in the temple area.4,5 They reported no serious adverse events (AEs) or occurrences of visual side effects. This was the first study assessing the safety and efficacy of a 20 mg/mL HA gel in the temple area. A careful injection technique was used and visual assessments were performed at each visit. The primary endpoint of this study was to determine the efficacy of a 20 mg/mL HA gel when used in the facial temporal regions based on the change in the score of the investigator’s Temporal Fossa Scale. It was also designed to evaluate the safety of a 20 mg/mL HA gel with particular attention to the incidence of vascular compromise, vascular events, and visual disturbances. The secondary endpoints were to identify the op- timal volume needed to correct temporal volume loss, evaluate the duration of correction at 12 months, and determine if adding temporal volume affected the subject’s self-perception of age appearance.

METHODS

Study Design

This was an open-label, single-center study composed of a treating investigator and 30 subjects. Subjects were injected with the 20 mg/mL HA gel to their right and left facial temporal regions at the baseline visit. Subjects received up to four 1-mL syringes of the 20 mg/mL HA gel for their initial injection and a maximum of six 1-mL syringes of the 20 mg/mL HA gel for