Bertucci, Vince

Importance Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.

Background: Aesthetic soft-tissue filler injections for lip enhancement are popular and performed throughout the world. When injecting lips with a cannula, as the cannula is advanced, resistance is perceived in consistent locations, potentially indicating boundaries between intralabial compartments. Objective: We aimed to investigate whether intralabial compartments exist and, if so, to describe their volumes, location, boundaries, and dimensions. Methods: This cadaveric study investigated a total of 20 human body donors (13 male, seven female) with a mean (SD) age at death of 61.9 years (23.9) and body mass index of 24.3 kg/m2 (3.7). The investigated cohort included 11 White donors, eight Asian donors, and one Black donor. Dye injections simulating minimally invasive lip treatments were conducted. Results: Independent of sex or race, six anterior and six posterior compartments in the upper and lower lip were identified, for a total of 24 lip compartments. Compartment boundaries were formed by vertically oriented septations that were found in consistent locations. The anterior compartments had volumes ranging from 0.30 to 0.39 cc; the posterior compartment volume ranged from 0.44 to 0.52 cc. The compartment volumes were larger centrally and decreased gradually toward the oral commissure. Conclusions: The volume and size of each of 24 compartments contribute to the overall appearance and shape of the lips. To achieve a natural lip shape preserving aesthetic outcome it may be preferable to administer the volumizing product using a compartment-respecting injection approach.

Background: The number of soft-tissue filler injections performed in the United States is constantly increasing and reflects the high demand for enhanced facial and body attractiveness. The objective of the present study was to measure the viscoelastic properties of soft-tissue fillers when subjected to different testing frequencies. The range of tested frequencies represents clinically different facial areas with more [lips (high frequency)] or less [zygomatic arch (low frequency)] soft-tissue movement. Methods: A total of 35 randomly selected hyaluronic acid–based dermal filler products were tested in an independent laboratory for their values of G′, G″, tan δ, and G* at angular frequencies between 0.1 and 100 radian/second. Results: The results of the objective analyses revealed that the viscoelastic properties of all tested products changed between 0.1 and 100 radian/second angular frequency. Changes in G′ ranged from 48.5 to 3116 percent, representing an increase in their initial elastic modulus, whereas changes in G″ ranged from −53.3 percent (i.e., decrease in G″) to 7741 percent (i.e., increase in G″), indicating both an increase and a decrease in their fluidity, respectively. Conclusions: The increase in G′ would indicate the transition from a “softer” to a “harder” filler, and the observed decrease in G″ would indicate an increase in the filler’s “fluidity.” Changes in the frequency of applied shear forces such as those occurring in the medial versus the lateral face will influence the aesthetic outcome of soft-tissue filler injections.

Abstract Background Injecting soft tissue fillers into the deep plane of the forehead carries the risk of injection-related visual compromise due to the specific course of the arterial vasculature. Objectives The aim of this study was to investigate the 2- and 3-dimensional location of the change of plane of the deep branch of the supratrochlear and supraorbital artery, respectively. Methods A total of 50 patients (11 males and 39 females; mean age, 49.76 [13.8] years, mean body mass index, 22.53 [2.6] kg/m2) were investigated with ultrasound imaging. The total thickness and the distance of the arteries from the skin and bone surface were measured with an 18-MHz broadband compact linear array transducer. Results The deep branch of the supraorbital artery changed plane from deep to superficial to the frontalis muscle at a mean distance of 13 mm (range, 7.0-19.0 mm) in males and at 14 mm (range, 4.0-24.0 mm) in females and for the deep branch of the supratrochlear artery at a mean distance of 14 mm in males and females (range, 10.0-19.0 in males, 4.0-27.0 in females) when measured from the superior orbital rim. Conclusions Based on the ultrasound findings in this study, it seems that the supraperiosteal plane of the upper and lower forehead could be targeted during soft tissue filler injections because the deep branches of both the supraorbital and supratrochlear arteries do not travel within this plane. The superficial plane of the lower forehead, however, should be avoided due to the unpredictability and inconsistent presence of the central and paracentral arteries. Level of Evidence: 4

Abstract Background Glabellar soft tissue filler injections have been shown to be associated with a high risk of causing injection-related visual compromise. Objectives The aim of this study was to identify the course of the superficial branch of the supratrochlear and of the deep branch of the supraorbital artery in relation to the ipsilateral vertical glabellar line and to test whether an artery is located deep to this line. Methods Forty-one healthy volunteers with a mean age of 26.17 [9.6] years and a mean BMI of 23.09 [2.3] kg/m2 were analyzed. Ultrasound imaging was applied to measure the diameters, distance from skin surface, distance between the midline, distance between vertical glabella lines, and the cutaneous projection of the supratrochlear/supraorbital arteries at rest and upon frowning. Results The mean distance between the superficial branch of the supratrochlear artery and the ipsilateral vertical glabellar line was 10.59 [4.0] mm in males and 8.21 [4.0] mm in females, whereas it was 22.38 [5.5] mm for the supraorbital artery in males and 20.73 [5.6] mm in females. Upon frowning, a medial shift in supratrochlear arterial position of 1.63 mm in males and 1.84 mm in females and of 3.9 mm in supraorbital arterial position for both genders was observed. The mean depth of the supratrochlear artery was 3.34 [0.6] mm at rest, whereas the depth of the supraorbital artery was 3.54 [0.8] mm. Conclusions The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected. Additionally, the glabella and the supraorbital region should be considered as an area of mobile, rather than static, soft tissues.

Abstract Background Lips are considered a key element of facial attractiveness due to their central position in the face and their elemental role in verbal and nonverbal communication. Objectives The authors sought to provide clinically relevant information on the 3-dimensional pathway of the superior and inferior labial arteries within the lips to increase safety during labial soft tissue filler injections. Methods The study enrolled 41 healthy volunteers with a mean age of 26.17 ± 9.6 years and a mean body mass index of 23.09 ± 2.3 kg/m2. Ultrasound imaging was performed at 6 different locations. The position of the labial arteries within the lips, depth of the arteries, cranio-caudal location of each artery in relation to the vermilion border, and diameter of the superior/inferior labial arteries were recorded. Results The most frequent location of both the superior and inferior labial arteries was the submucosal plane (58.5%) followed by intramuscular (36.2%) and subcutaneous (5.3%) planes. The depth of the superior labial artery in the upper lip was 5.6 ± 0.13 mm, whereas the depth of the inferior labial artery in the lower lip was 5.2 ± 0.14 mm. Both arteries were more frequently located within the red lip: upper lip (83% vs 18.7%) and lower lip (86.2% vs 13.8%). In the midline, the artery coursed within the red lip in all investigated volunteers. Conclusions Clinically, results of this study favor a superficial injection plane for lip volumization procedures. A perpendicular approach to the lip (coming from the cutaneous lip) might increase safety because the artery is located most frequently within the red lip.