Midface Volume Research Articles

Safety and Effectiveness of Large Gel Particle Hyaluronic Acid with Lidocaine for Correction of Midface Volume Loss

Midface volume loss and contour deficiency are often treated using soft-tissue fillers capable of elevating and supporting facial features. To evaluate the effectiveness and safety of large gel particle hyaluronic acid with 0.3% lidocaine (LGP-HA-L) for the treatment of midface volume loss or contour deficiency. This 24-week, open-label study recruited adults aged 18 to 65 with bilateral moderate to substantial midface volume loss or contour deficiency (Medicis Midface Volume Scale (MMVS) score 3-4). The primary effectiveness measure was MMVS response (≥1-grade improvement) 8weeks after treatment according to evaluators blinded to injection volume. All enrolled patients (n=40; 85.0% female; mean±SD age 53.1±7.0 years) completed the study. Mean±SD injected volume for both sides of the midface was 5.3±2.5 mL. Week 8 MMVS response rates were 97.5% according to blinded evaluators and treating investigators and 90.0% according to patients; week 24 rates were 90.0%, 92.5%, and 82.5%, respectively. Global Aesthetic Improvement Scale response rates were 95.0% to 100.0% throughout the study. Adverse events were reported in 60.0% of patients and were mild or moderate; all resolved by study end and most within 1week. Midface volume loss or contour deficiency may be safely and effectively corrected using LGP-HA-L.

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: 2-Year Results from a Pivotal Single-Blind Randomized Controlled Study

Hyaluronic acid (HA) gels are commonly used to correct age-related midface volume deficit (MVD), yet the Food and Drug Administration has not specifically approved them for this purpose. To study the safety and effectiveness of a new 20-mg/mL HA gel (VYC-20L) specifically formulated and optimized for mid-face volumizing. A multicenter, single-blind, controlled study randomized 235 subjects aged 35 to 65 with MVD to a treatment group and 47 to a no-treatment control group. Responders were defined as subjects who achieved improvement of 1 point or more on the validated 6-point Mid-Face Volume Deficit Scale (MFVDS) at 6months as rated live by two blinded independent evaluators. The primary endpoint required a 70% or greater treatment group response and a statistically significant difference (p<.001) between the treatment and control group responder rates. The primary endpoint was met, with 85.6% of the treatment group improving by 1 point or more on the MFVDS at month 6 and a statistically significant difference (p<.001) between the treatment and control group responder rates. Subjects tolerated VYC-20L well, with no unanticipated adverse device effects. Nearly half of subjects maintained correction for 24months. VYC-20L is safe and effective for age-related MVD, with correction lasting up to 2years.

Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study

BackgroundHyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects.MethodsSubjects received treatment with Juvéderm™ Voluma™ to the malar area, based on the investigators’ determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS).ResultsOf the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma™ at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma™, with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported.ConclusionVoluma™ is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.

Validation of a Four-Point Photographic Scale for the Assessment of Midface Volume Loss and/or Contour Deficiency

Soft-tissue augmentation with injectable fillers is commonly performed in the malar area. A four-point scale, the Medicis Midface Volume Scale, was developed and validated as an objective measure of the severity of midface volume loss. Using a separate photographic guide, four investigators rated photographs (front and right and left sides, to provide a full view of the face) of 60 untreated subjects in random order during two sessions 2 or more weeks apart. Both sides of the midface were scored separately as follows: 1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing. Most subjects (mean age, 45.7 years; range, 23 to 80 years) were women (72 percent) and white (87 percent). Intraobserver agreement between sessions was "almost perfect" (weighted kappa scores) for the right (0.918; 95 percent CI, 0.887 to 0.949) and left (0.911; 95 percent CI, 0.878 to 0.943) sides. Intraobserver exact agreement between sessions was 87.1 percent (range, 76.7 to 95.0 percent) for the right side and 86.3 percent (range, 76.7 to 95.0 percent) for the left. Interobserver agreement was "substantial" to "almost perfect" (weighted kappa scores) for the right (0.759 to 0.893) and left (0.758 to 0.888) sides. Interobserver exact agreement was 72.5 to 87.5 percent for the right side and 72.5 to 86.7 percent for the left. Overall, results were similar in nonwhite and white subjects. Consistent agreement by different evaluators and the same evaluator at different times validates the four-point Medicis Midface Volume Scale as suitable to objectively measure the severity of midface volume loss. Diagnostic IV.

Global, 3‐dimensional approach to natural rejuvenation: part 1 – recommendations for volume restoration and the periocular area

New techniques and products have lead to a global approach for the treatment of signs of aging. However, there is little published literature on the procedures involved in this approach and currently no validated recommendations exist. To provide a detailed, practical guide to midfacial volume restoration and rejuvenation of the periocular area based on expert consensus recommendations. The expert committee took into account both volumetric and dynamic aspects of treatment, as well as benefits of treatment combinations, for example, combining OnabotulinumtoxinA with hyaluronic acid (HA) fillers and volumizers. An aging severity scale was established for each area, together with recommendations of appropriate products, doses, site, depth, and injection techniques, as well as rules to be respected. The expert group concluded that volume restoration of the midface is the first essential step in the global approach because treatment for this area has the most significant positive impact. Firstly, it is important to restore the malar contour, as malar volume anchors the structure of the midface. Secondly, an assessment of the effects of malar enhancement on the appearance of the nasolabial folds and the nasojugal fold (tear trough) should be conducted because these aging signs may be decreased by malar enhancement. Finally, treatment for the nasolabial folds and periorbital area with HA should be performed when needed. Practical guidance is provided for midfacial volume restoration and rejuvenation of the periocular area based on validated expert consensus recommendations. This will help esthetic facial physicians to achieve optimum outcomes.

Reflective account of a delayed adverse reaction to a large molecular filler

This is a reflective account of a 62-year-old woman (Jean) who developed delayed hypersensitivity reactions to a large molecular hyaluronic acid (HA) filler in 2009. Jean had previous injections in August 2008 of 1 ml of HA filler to her nasolabial folds, of 1 ml of HA filler to the peri-oral area in November 2008 and 1 ml of HA filler to nasolabial folds in May 2009, all with excellent results and high patient satisfaction. However, Jean presented 10 weeks after her initial treatment for mid-face volume loss with a volumising HA dermal filler and developed an adverse delayed reaction. Following this experience, the author formed a protocol for her clinic and has taken part in discussions about protocols in practice, prescribing and managing complications.

Three-dimensional digital surface imaging measurement of the volumizing effect of injectable poly-l-lactic acid for nasolabial folds

Introduction: Injectable poly-l-lactic acid (PLLA) is a biocompatible and biodegradable polymer device indicated in Europe for correction of facial contour deficiencies, with a gradual onset of effect that is maintained for up to 25 months. Methods: In this single-centre, open-label study, 20 adult subjects seeking treatment for facial contour deficiencies were treated with injectable PLLA every 4–6 weeks for ≤6 months or until optimal correction (0 or 1 on nasolabial photonumeric wrinkle assessment scale [0 = no wrinkles; 5 = very deep wrinkles, redundant fold]). 3-D digital surface imaging and standardized 2-D photography were used to assess mid-face and nasolabial volumetric correction and clinical improvement, respectively. Results: Based on 3-D digital surface imaging, statistically significant increases in average mid-facial volume occurred with injectable PLLA after the first injection session and persisted through to the end of treatment. Investigator and subject ratings of ‘much improved’ or ‘excellent’ improvement were reported using 2-D photographs as a visual aid. Subjects reported high levels of satisfaction. No serious adverse events were reported. Discussion: In this study, injectable PLLA was found to be safe and effective for mid-face and nasolabial fold volumetric correction.

Anatomy and Nonsurgical Correction of the Tear Trough Deformity

The development of dark circles under the eyes is one of the early signs of periorbital aging, lending a fatigued and aged appearance to the face. Loeb, in 1961, used the term "nasojugal groove" to describe the concavity at the border of the eyelid and the cheek medially. Flowers, in 1969, first named this groove the "tear trough." In the present article, the author presents a detailed description of the anatomy and nonsurgical correction of this deformity. Nonsurgical correction of the tear trough deformity with hyaluronic acid is effective and safe and is associated with high patient satisfaction. The procedure offers both an adjunct to surgery and an alternative to it in some patients. It also provides an opportunity for global midfacial volume correction. Careful patient selection and attention to technique will minimize side effects.

Effect of Injection Techniques on the Rate of Local Adverse Events in Patients Implanted with Nonanimal Hyaluronic Acid Gel Dermal Fillers

One question associated with dermal fillers is whether the rate and variability of local adverse events following treatment are related to injection technique and needle trauma or to the intrinsic chemical composition. The objective was to determine if there is a relationship between dermal filler injection technique and the incidence of local adverse events. A prospective, blinded, controlled study enrolled 283 patients who were randomized to receive midface volume correction of the nasolabial folds and oral commissures with the nonanimal-stabilized hyaluronic acid (NASHA) gel filler Restylane or Perlane (Medicis Pharmaceutical Corp.). Data were collected on multiple injection technique variables to assess adverse events. Injection techniques that increase the dissection of the subepidermal plane (e.g., fanlike needle use, rapid injection, rapid flow rates, and higher volumes) increased the incidence of local adverse events. Injection techniques that increase epidermal damage or subcutaneous exposure (e.g., multiple punctures or deep subcutaneous injection) had no effect on adverse events. Furthermore, single injection correction, depth of injection, and NASHA product injected had no effect on local adverse events. Local adverse events following injection with the NASHA gel fillers used in this study were related to investigator technique and not to differences in the intrinsic properties of the NASHA agents.

Effect of Injection Techniques on the Rate of Local Adverse Events in Patients Implanted with Nonanimal Hyaluronic Acid Gel Dermal Fillers

BACKGROUND One question associated with dermal fillers is whether the rate and variability of local adverse events following treatment are related to injection technique and needle trauma or to the intrinsic chemical composition. OBJECTIVE The objective was to determine if there is a relationship between dermal filler injection technique and the incidence of local adverse events. METHODS AND MATERIALS A prospective, blinded, controlled study enrolled 283 patients who were randomized to receive midface volume correction of the nasolabial folds and oral commissures with the nonanimal-stabilized hyaluronic acid (NASHA) gel filler Restylane or Perlane (Medicis Pharmaceutical Corp.). Data were collected on multiple injection technique variables to assess adverse events. RESULTS Injection techniques that increase the dissection of the subepidermal plane (e.g., fanlike needle use, rapid injection, rapid flow rates, and higher volumes) increased the incidence of local adverse events. Injection techniques that increase epidermal damage or subcutaneous exposure (e.g., multiple punctures or deep subcutaneous injection) had no effect on adverse events. Furthermore, single injection correction, depth of injection, and NASHA product injected had no effect on local adverse events. CONCLUSIONS Local adverse events following injection with the NASHA gel fillers used in this study were related to investigator technique and not to differences in the intrinsic properties of the NASHA agents.

Endoscopic temporal-incision only midface lift is enhanced by endotine technique

The Endotine midface technique, through an endoscopic temporal-incision only approach, is the author's preferred method of malar fat pad suspension and fixation. The bioabsorbable Endotine device avoids an intraoral incision, eliminates sutures, offers multipoint fixation, and the leash fixation mechanism provides fast and simple adjustability for optimal control of midface elevation and volume.

Discussion ‘Midface Volume Replacement with a Transmaxillary Implant’, by Steven Burres

Discussion ‘Midface Volume Replacement with a Transmaxillary Implant’, by Steven Burres

Midface Volume Replacement with a Transmaxillary Implant

Volume replacement is an essential component of midface rejuvenation. Previously designed alloplastic implants augment bony prominences. The Maxout implant was configured to add height to the lowest surface, the canine fossa. A random series of patients, from an office-based practice requested midface augmentation. Three of these patients were human immunodeficiency virus (HIV) positive. With the patient under local anesthetic, bilateral Maxout implants were inserted through either an intraoral or an intranasal incision. All the implants produced a satisfactory aesthetic improvement. In one HIV-positive patient, one implant placed intraorally became infected and required removal. It was replaced 3 months later through the transnasal approach. All the patients had retained their implants 1 year later. The Maxout implant is easy to insert and remove, aesthetically effective, secured by bone structures, and located in a neutral position. The risk of infection must be considered, especially for HIV-positive patients.

External craniofacial features, body size, and renal morphology in prenatal Brachyrrhine mice

The Brachyrrhine (Br) semidominant mouse mutant provides a useful model for studying factors responsible for midfacial hypoplasia. In order to determine early morphogenetic events responsible for midfacial hypoplasia in these mice, prenatal mutants must be differentiated from nonaffected littermates. The purpose of this study was to determine whether prenatal offspring from Br matings could be separated morphologically into groups of normal or midfacially deficient embryos. Thirty embryos resulting from Br matings were collected between day 15 and birth (Theiler stages 23-27). Qualitative observations on craniofacial morphology as well as renal morphology and histology suggested that embryos segregated into two distinct groups. External craniofacial and body measurements, collected from the embryos, as well as renal volumes, determined from computerized reconstructions of the kidneys, were subjected to quantitative analyses. A discriminant function analysis segregated the sample into two groups based primarily on midfacial length and renal volume. Bivariate regression analysis showed that midfacial length and renal volume differed significantly, and cranial length marginally so, between the two groups. The results indicate that a proportion of prenatal offspring from Br matings exhibits midfacial and renal hypoplasia and that these animals segregate completely from nonaffected embryos.