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
