Hyaluronic Acid Filler VYC-25L for Jawline Restoration Yields High Satisfaction, Improved Jawline Measurements, and Sustained Effectiveness Across Skin Types, Age, and Gender for up to 12 Months

Abstract

Background

A randomized study previously reported demonstration of the safety and efficacy of hyaluronic acid filler VYC-25L for restoring jawline definition.

Objectives

The aim of this study was to evaluate patient-reported outcomes (PROs), objective changes in jawline profile, and safety and effectiveness measures by Fitzpatrick skin phototype (FST), gender, and age following VYC-25L treatment.

Methods

Adults were randomized to receive VYC-25L (n = 157) or no treatment (control; n = 49) for 6 months. PROs were assessed by FACE-Q Satisfaction with Lower Face and Jawline, FACE-Q Appraisal of Lines: Marionette, and participant satisfaction with treatment questionnaires. Changes in jawline profile linear depth and volume were calculated with 3-dimensional digital image analysis. Responder rates, PROs, and injection site responses (ISRs) were assessed by FST, gender, and age.

Results

At Month 6, >70% of treated participants responded “somewhat/very satisfied” to FACE-Q Satisfaction with Lower Face and Jawline questions, and ≥78% of treated participants responded “satisfied/definitely satisfied” with treatment overall. For participants treated for the marionette lines, the FACE-Q Appraisal of Lines: Marionette questionnaire mean score improved by 32.6 (baseline to Month 6). Mean change in linear depth in the prejowl sulcus in the treatment vs control groups was 4.6 mm vs 2.5 mm, respectively, and for jawline volume was 6.0 mL and -2.6 mL, respectively (baseline to Month 6). Subanalyses showed similar outcomes by FST, gender, and age, except for a numerically higher ISR incidence in females vs males.

Conclusions

Treatment with VYC-25L to improve jawline definition yielded high patient satisfaction, objective improvements in jawline profile, and comparable effectiveness across various demographics.

Level of Evidence: 2

A well-defined jawline is considered attractive and aesthetically pleasing.¹ However, age-related changes to the face, including mandibular bone resorption, skin laxity, and redistribution of facial fat and soft tissue, or congenital issues, can lead to the loss of jawline definition, prompting many individuals to seek treatment to restore volume and improve the jawline profile.^2-5 Hyaluronic acid (HA) filler injections are a nonsurgical treatment option to lift, shape, and provide contour to facial areas including the chin and jawline, to achieve more balanced facial proportions.^6-10

Recent demographic trends related to facial aesthetic procedures highlight the importance of understanding treatment effects by subpopulations, including skin type, patient age, and gender.⁵ For example, facial volume restoration and aesthetic procedures, such as injections with soft tissue fillers, are becoming more common in individuals with skin of color.^11,12 Further, although most soft tissue filler procedures are performed in females, male interest in seeking minimally invasive treatment for facial aesthetic concerns is increasing; a 2018 survey reported a 25% increase in the use of fillers in males between 2012 and 2017.^12-15 Frequency and treatment area preference of aesthetic procedures vary across age brackets, as well. Of nonsurgical aesthetic procedures in the United States, 17% were performed in patients ages 17 to 35 years, 41% in patients ages 36 to 50 years, 37% in patients ages 51 to 70 years, and 5% in patients ages ≥71 years.¹⁰ A study of facial treatment areas by age group reported that females ages 60 to 65 years had a >20% increase in their treatment preference for the jawline and marionette lines vs females ages 30 to 35 years.⁸

Treatment with the HA injectable gel VYC-25L is designed to restore aging-related loss of jawline definition or to improve congenital jawline deficits in younger patients.^16,17 VYC-25L was shown to be a safe and effective nonsurgical treatment option for improving jawline definition and restoring jawline volume in a previously reported, evaluator-blinded, multicenter, randomized, pivotal clinical trial in >200 adults with moderate to severe loss of jawline definition.¹⁸ The treatment group showed a statistically significant increase in responder rate (≥1-point improvement for both sides on the Allergan Loss of Jawline Definition Scale [ALJDS]) at 6 months posttreatment compared with the control group (the primary effectiveness endpoint) and a significant improvement from baseline in mean FACE-Q Satisfaction with Lower Face and Jawline overall scores. Investigator-assessed Global Aesthetic Improvement Scale (GAIS) demonstrated an 89% responder rate in the treatment group at Month 6.¹⁸ The current report describes additional effectiveness measures from this study, including participant satisfaction, as well as objective jawline measurements, which quantify the clinical effects of treatment to complement the subjective endpoints presented here and in our previous report. Subset analyses of safety and effectiveness endpoints by skin type, gender, and age group are also presented to assess the generalizability of our results to a diverse population.

METHODS

Study Design

The design of this multicenter (19 sites), evaluator-blinded, parallel-group, randomized controlled study has been described elsewhere.¹⁸ Briefly, participants were randomly assigned 3:1 based on a central randomization schedule to receive VYC-25L (Juvéderm Volux XC; Allergan Aesthetics, an AbbVie Company, Irvine, CA) treatment to the jawline at study onset (treatment group), or no treatment for 6 months (control group). Randomization and treatment assignments were performed with an automated interactive web response system. At Day 30, the treatment group could receive an optional touch-up treatment if they had not achieved at least a 1-grade improvement on each side of the jawline on the validated, 5-point ALJDS (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme), as assessed by the treating investigator (TI). Participants in the treatment group were offered an optional maintenance treatment at Month 12 with an additional 3-month follow-up period. After the 6-month no-treatment period, the control group either completed the study or received optional VYC-25L treatment (initial and touch-up 30 days later, if needed), followed by a 12-month follow-up period and no optional maintenance treatment (posttreatment control group). Participants in the treatment group were assessed for effectiveness and safety endpoints at Months 1, 3, and 6 (primary endpoint); 9 and 12 after the last treatment (initial or touch-up); and at Months 1 and 3 after optional maintenance treatment. Participants in the control group were assessed at Months 1, 3, and 6 after randomization and, for those receiving optional treatment, effectiveness assessments (for 6 months) and safety assessments (for 12 months) were conducted after the last treatment.

VYC-25L volume distribution and injection techniques have been previously described.¹⁸ Briefly, VYC-25L was injected with a 27-G, 0.5-inch needle, 25-G, 1.5-inch cannula, or both, based on the TI's preference. Treatment consisted of VYC-25L injections into the prejowl and postjowl areas, chin, marionette lines (optional), and the mandibular body and angle at initial treatment, with the option of a touch-up treatment 30 days later. The maximum volume of VYC-25L initial and touch-up treatments combined was 8 mL.

This study received institutional review board approval (Copernicus Group IRB, Cary, NC), was conducted in compliance with Good Clinical Practice guidelines, and included written informed consent from participants.

Inclusion and Exclusion Criteria

Eligible participants were adults ages 22 years or older with moderate (ALJDS grade 2) or severe (grade 3) loss of jawline definition on both sides (both sides of the jaw had to be eligible but both sides did not need to have the same score) as assessed by the evaluating investigator (EI) with the ALJDS scale and deemed by the TI to be amenable to improvement of at least 1 grade on the ALJDS. Participants were excluded if they had previous or planned facial implants, lower two-thirds facial fat injections, laser procedures, chemical peels, liposuction, mesotherapy, semipermanent dermal filler treatment within 36 months, or temporary filler treatment below the subnasale within 12 months of enrollment. Additional exclusion criteria consisted of any history of botulinum toxin injections in the lower face or deoxycholic acid treatment in the submental region in the last 6 months before enrollment; severe midface volume deficit, prominent submental fat fullness, extreme skin laxity, or significant facial asymmetry; history of trauma to the chin and jaw area within 6 months of enrollment, or residual deficiencies, deformities, or scarring; or allergy to lidocaine, HA products, or streptococcal protein.

Effectiveness Measures

Primary and Secondary Effectiveness Endpoints

The primary effectiveness endpoint was the ALJDS responder rate, defined as participants with ≥1-point ALJDS improvement from baseline on both sides of the jawline according to the EI, based on participant photographs.

Secondary effectiveness endpoints included change from baseline at Month 6 in mean overall participant satisfaction with the jawline after treatment with the validated FACE-Q Satisfaction with Lower Face and Jawline 5-item questionnaire.¹⁹ The items evaluated were: jawline prominence, jawline definition, facial profile, lower face smoothness, and lower facial appearance. Paper questionnaires were provided to the participants by site staff, and participants evaluated each item on a 4-point scale (1 = very dissatisfied; 2 = somewhat dissatisfied; 3 = somewhat satisfied; 4 = very satisfied).

In addition, both the EI and participants assessed GAIS responder status noncollaboratively with digital photographs. At each time point posttreatment, the EI assessed GAIS for both control and treatment groups. Only treated participants performed a GAIS self-assessment. A GAIS responder was defined as a participant with a rating of “improved” or “much improved” in overall jawline area aesthetics at Month 6 on the 5-point GAIS (2 = much improved; 1 = improved; 0 = no change; −1 = worse; −2 = much worse).

Other Effectiveness Assessments

Mean overall scores and proportions of participants who responded they were “a little” or “not at all” bothered to questions about the appearance and aesthetic impact of their marionette lines on the validated FACE-Q Appraisal of Lines: Marionette questionnaire (according to a 4-point scale consisting of “extremely,” “moderately,” “a little,” or “not at all” bothered) were collected for participants who were treated with VYC-25L in the marionette lines. Participant satisfaction with treatment overall, natural look, and natural feel was recorded on a 5-point scale (ie, definitely dissatisfied, dissatisfied, no opinion, satisfied, definitely satisfied). Treated participants who would recommend the treatment to a friend (ie, yes or no) were recorded at Months 6 and 12 during the treatment period and Month 3 after repeat treatment.

Objective Jawline Measurements

Linear depth changes (in mm) and volumetric changes (in mL) in jawline profile were assessed by 3-dimensional (3D) facial digital image analysis at Months 1, 3, 6, 9, and 12 during the treatment period and 14 days, 1 month, and 3 months after maintenance treatment (digital image analysis provided by Canfield Scientific, Parsippany, NJ). Figure 1 shows the location of the key areas of interest measured (mean linear depth change on the prejowl sulcus and mean volumetric change in the jawline profile).

Figure 1.

Jawline profile parameters measured with 3-dimensional imaging: arrow represents linear depth change at the point of the largest projection, indicated by the X, within the prejowl sulcus, which is shaded. Volumetric change is the change in the jawline profile area enclosed by the dotted line.¹⁸

Skin Type, Gender, and Age Subgroup Analyses

Analyses of the ALJDS responder rate (primary endpoint), change from baseline on FACE-Q Satisfaction with Lower Face and Jawline, EI- and participant-assessed GAIS responders, and incidence of injection site responses (ISRs) were conducted by subgroups: skin types I-III vs IV-VI on the Fitzpatrick skin phototype (FST) scale, gender (female vs male), and age group (26-57 years of age [generation X/millennial] vs 58 years of age or older [baby boomer and older]).^20,21 Due to the small sample sizes, generation X and millennials were combined to provide meaningful comparison with baby boomers.

Safety Analyses

Other safety analyses, as previously described, included incidence of adverse events (AEs), ISRs, procedural pain scores, jaw function testing, facial sensation assessment, pronunciation video recordings, and incidence of AEs of special interest (vision-related).¹⁸ The safety population consisted of all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group.

Statistical Analysis

Statistical methodologies employed to evaluate primary and secondary endpoints were previously reported.¹⁸ Briefly, the primary endpoint was met when both a P < .025 on a 1-sided Fisher's exact test and a treatment group responder rate of >50% were achieved. The last observation carried forward method was performed to impute missing values at Month 6. GAIS was analyzed with responder rates with 95% confidence intervals (CIs). For the FACE-Q Satisfaction with Lower Face and Jawline questionnaire, raw scores of the individual items for each scale were summed to provide the total raw individual and total scores and then transformed by Rasch unidimensional methods to create a score ranging from 0 to 100, with higher scores reflecting a better outcome. Data were analyzed with the 2-sided paired t test at the 5% level (eg, Month 6 score vs baseline).

Other effectiveness and exploratory data were summarized with descriptive statistics, such as mean, standard deviation, minimum, median, and maximum. Statistical tests, when appropriate, were performed with 2-sided 95% CIs.

RESULTS

Study Population

A total of 271 participants were screened, and 206 participants were randomized (treatment, n = 157; control, n = 49). The analysis population had a mean (SD) age of 59.0 (8.5) years (median 59 years; range 26-81) and were mainly female (87.4%) and White (84.5%). At baseline, based on ALJDS scores, 72.8% of participants (n = 150) had severe loss of jawline definition, 22.8% (n = 47) had moderate loss, and 4.4% (n = 9) had extreme loss. FST I/II, III/IV, and V/VI accounted for 33.0%, 53.4%, and 13.6% of the participants, respectively.¹⁸ In the treatment group, approximately one-half of participants (52.6%; 82/156) were injected by needle only and the other one-half (47.4%; 74/156) by cannula (with or without needle). Among the participants who received maintenance treatment, 66.7% (58/87) of participants were injected by needle only vs 33.3% (29/87) by cannula (with or without needle). Of 206 participants, 196 (95.1%; treatment, n = 149; control, n = 47) participants completed the Month 6 control period and 179 (86.9%; treatment, n = 139; control, n = 40) participants completed the study.

Participant-reported Outcomes and Satisfaction Assessments

The proportions of treated participants who responded “somewhat satisfied” or “very satisfied” to the individual questions on the FACE-Q Satisfaction with Lower Face and Jawline questionnaire showed substantial improvements from baseline to Month 6 in satisfaction with jawline prominence and definition, jawline profile appearance, and lower face appearance and smoothness (ie, no jowls or folds of fatty skin; Figure 2). The majority of participants remained somewhat satisfied or very satisfied at Month 12.

Figure 2.

Participant FACE-Q Satisfaction with Lower Face and Jawline improvements (proportions responding “somewhat satisfied” or “very satisfied” to each questionnaire item). *n = 145 for “How nice your lower face looks” at Month 6.

The mean overall scores on the FACE-Q Appraisal of Lines: Marionette questionnaire showed improvement from baseline at all time points among participants receiving initial and/or touch-up treatment of the marionette lines (Figure 3A). Overall scores were similar at Month 3 after maintenance treatment (66.5) compared with Month 3 after initial treatment (69.4). The majority of marionette line–treated participants continued to show improved satisfaction with their marionette lines for 12 months after treatment. The proportions of marionette line–treated participants who responded “a little” or “not at all” to individual questions from the FACE-Q Appraisal of Lines: Marionette questionnaire about how sad, tired, or old their marionette lines made them look, or how noticeable the lines were, reflected high levels of satisfaction with marionette line treatment with VYC-25L at Months 6 and 12 compared with baseline (Figure 3B).

Figure 3.

FACE-Q Appraisal of Lines: Marionette questionnaire results in marionette-treated participants: (A) mean scores and (B) proportions responding “a little” or “not at all” bothered on selected questions.

On the participant satisfaction with treatment questionnaire, a majority of treated participants (≥89% at Month 1, ≥ 78% at Month 6, and ≥60% at Month 12) responded “satisfied” or “definitely satisfied” to questions about satisfaction with treatment overall, natural look, and natural feel during the treatment period (Figure 4). At Month 3, after maintenance treatment, >91% of participants (n = 85) were satisfied with treatment overall, natural look, and natural feel. The proportions of treated participants who said they would recommend the treatment to a friend were 89.7% at Month 6 (n = 146), 87.2% at Month 12 (n = 141), and 97.6% at Month 3 (n = 85) after maintenance treatment.

Figure 4.

Participants' levels of satisfaction with treatment overall and with natural look and feel.

Objective Jawline Measurements

The overall mean change in linear depth of the prejowl sulcus was 4.6 mm at Month 6 in the treatment group vs 2.5 mm in the control group (Figure 5A). Results were similar (ie, 4.1 mm) through Month 6 for the participants in the posttreatment control group. In the maintenance treatment population, the mean change from baseline at Month 3 after maintenance treatment was 5.4 mm.

Figure 5.

Change from baseline after VYC-25L treatment in (A) Prejowl sulcus linear depth and (B) jawline profile volume.

Volumetric measurement of the jawline profile showed an overall mean volume change at Month 6 of 6.0 mL in the treatment group vs −2.6 mL in the control group (Figure 5B). This treatment group had received a median injected volume of 4.35 mL VYC-25L for initial treatment, and 2.0 mL for touch-up treatment, with a median combined total injected volume of 6.8 mL. Similar results (ie, 6.5 mL) were observed in the posttreatment control group (median combined total injected volume of 6.55 mL) through Month 6 after initial treatment and touch-up. The mean change from baseline was 11.4 mL at Month 3 after maintenance treatment with a median 3.0 mL of VYC-25L injected for maintenance treatment.

Skin Type, Gender, and Age Subgroup Analyses

ALJDS responder rates (Figure 6) and change from baseline in mean FACE-Q Satisfaction with Lower Face and Jawline transformed scores (Supplemental Figure 1, located online at www.aestheticsurgeryjournal.com) were similar among subgroups at Months 6 and 12 regardless of FST, gender, and age group. EI-assessed GAIS responder rates were similar regardless of skin type, gender, and age group (Supplemental Figure 2, located online at www.aestheticsurgeryjournal.com), with higher rates by a minimum of 57% with treatment vs control at Month 6. Participant-assessed GAIS responder rates were similarly and consistently high (≥72%) through Month 12 across skin type, gender, and age subgroups (Supplemental Figure 3, located online at www.aestheticsurgeryjournal.com).

Figure 6.

ALJDS responder rates by Fitzpatrick skin phototype (FST), gender, and age group. ALJDS, Allergan Loss of Jawline Definition Scale.

Safety

As previously reported, VYC-25L was well tolerated, with minimal procedural pain and no compromise to vision, jaw function, sensation, or pronunciation.¹⁸ Most treatment-emergent AEs were mild in severity, and most ISRs were mild or moderate and resolved within 2 weeks postinjection. The most common ISRs after initial treatment were tenderness to touch (80.1%), lumps/bumps (79.1%), and pain after injection (78.1%). When analyzed by age group and skin type, the incidence of ISRs was similar to that observed in the safety population (Table 1), but there was a higher ISR incidence for females vs males (87.4% vs 68.2%).

Table 1.

Analysis of ISRs by Subgroups in VYC-25L–Treated Participants^a

n (%)	Male n = 22	Female n = 174	Age 26-57 years n = 46	Age ≥58 years n = 150	Skin type I/II/III n = 131	Skin type IV/V/VI n = 65
Any ISR	15 (68.2)	152 (87.4)	39 (84.8)	128 (85.3)	111 (84.7)	56 (86.2)
Tenderness to touch	12 (54.5)	145 (83.3)	37 (80.4)	120 (80.0)	107 (81.7)	50 (76.9)
Lumps/bumps	12 (54.5)	143 (82.2)	34 (73.9)	121 (80.7)	106 (80.9)	49 (75.4)
Pain after injection	12 (54.5)	141 (81.0)	37 (80.4)	116 (77.3)	105 (80.2)	48 (73.8)
Swelling	11 (50.0)	141 (81.0)	34 (73.9)	118 (78.7)	104 (79.4)	48 (73.8)
Bruising	7 (31.8)	129 (74.1)	33 (71.7)	103 (68.7)	97 (74.0)	39 (60.0)
Firmness	13 (59.1)	131 (75.3)	33 (71.7)	111 (74.0)	97 (74.0)	47 (72.3)
Redness	9 (40.9)	124 (71.3)	30 (65.2)	103 (68.7)	89 (67.9)	44 (67.7)
Itching	5 (22.7)	60 (34.5)	19 (41.3)	46 (30.7)	45 (34.4)	20 (30.8)
Discolorationb	3 (13.6)	61 (35.1)	14 (30.4)	50 (33.3)	46 (35.1)	18 (27.7)

ISR, injection site response. ^aIncludes participants in the VYC-25L treatment group and posttreatment control group. ^bNo redness or bruising.

DISCUSSION

The lower third of the face, particularly the jawline, can have a major impact on overall facial appearance.^3,22 A well-contoured jawline, distinguished by a defined line from the mandibular angle to the chin, is desirable in both males and females and contributes to perceptions of youth and beauty.^3,22,23 Enhancements to jawline profile, angle, and symmetry achieved with jawline contouring and restoration procedures may have psychological benefits for treated individuals, including improved satisfaction with appearance, increased psychological and social well-being, and improved perceptions of attractiveness and positive personality traits.^6,24-26 Dermal filler injections for jawline enhancement are becoming a popular nonsurgical option for lower facial rejuvenation.²² Other features distinguishing HA fillers from other procedures are high injector familiarity and reversibility of HA filler injection with hyaluronidase if needed.^27-29 Given the jawline's key role in facial aesthetics and its psychosocial impact on individuals, this pivotal study provides additional support for the effectiveness of VYC-25L for improving jawline definition.

In clinical studies, tools for measuring the effectiveness of facial aesthetic treatments may be objective or subjective. Objective measures are generally instrumentation-based assessments that quantify the clinical effects of a treatment and are less prone to bias (eg, linear depth and volumetric changes by 3D facial digital imaging methods).^30,31 Subjective measures rely on individual interpretation of perceived improvements in aesthetic features, self-image or self-esteem, overall satisfaction with outcomes, and quality of life (eg, validated clinical rating scales, such as the ALJDS or FACE-Q).^31,32 In facial aesthetics, subjective measures are key assessments because aesthetic procedures are often voluntarily undertaken by participants seeking to improve their appearance and psychosocial well-being, goals that are not addressed by objective measures.^30,32,33 This study, which combined objective and subjective methodologies to measure the effectiveness of VYC-25L, provides a more comprehensive appraisal of posttreatment changes in jawline profile, participant satisfaction, and effectiveness by study subpopulations.

The findings reported here show durable improvements in self-reported satisfaction with the look and feel of the jawline and lower face on the FACE-Q Satisfaction with Lower Face and Jawline questionnaire among VYC-25L–treated participants. Moreover, the high satisfaction reported by participants who received treatment of their marionette lines provides previously unexplored data related to the feasibility and effectiveness of simultaneously addressing multiple areas of the lower face when administering injectable treatments designed to restore jawline definition. High participant satisfaction was also evident from the participants' responses to the direct question on treatment satisfaction. At Month 12, 68% of treated participants in this study were still satisfied with VYC-25L treatment and 87% would recommend VYC-25L treatment for jawline restoration to a friend, demonstrating that there was a durable improvement appreciated by participants.

The current study results lend further support to previous studies reporting high participant satisfaction with VYC-25L injections to the lower face. A prospective European study of VYC-25L for the treatment of chin retrusion in 119 adults reported on investigator- and participant-assessed improvements with the lower face and jawline.²⁴ Investigator- and participant-assessed GAIS scores were improved or much improved in 100% of investigators and 91.8% of participants at 3 months following initial treatment.²⁴ Improvements from baseline in mean FACE-Q Satisfaction with Lower Face and Jawline scores were reported by 95.3% of participants at Month 3 and 86.3% at Month 12. A retrospective, 6-month, single-center analysis of data from 30 adults undergoing treatment of the chin and jawline with VYC-25L showed the filler to be safe and effective, with high rates of participant satisfaction. A large majority of participants (96.7%) rated their appearance 20 days posttreatment as “much improved” or “very much improved” on the GAIS.²⁹ These studies further support VYC-25L for shaping and sculpting high-mobility facial areas of the chin and jawline.

The objective analyses of jawline profile conducted in this study with 3D imaging showed improvements in mean linear depth and volume of the jawline profile from baseline through Month 12 after treatment, confirming the effectiveness of VYC-25L for restoring jawline profile in participants with moderate or severe loss of jawline definition. These measurements were comprehensive. In addition to volumetric measurements, linear depth change at the prejowl sulcus was selected because it measures a more discrete area than jawline volume and is a key location for assessments based on the ALJDS.

Improvements in objective facial measures following VYC-25L treatments have been reported in other studies utilizing 3D photography. A European investigation of VYC-25L for chin retrusion and jawline restoration in 119 adults found significant improvements in the glabella–subnasale–pogonion facial angle as measured by 3D digital facial image analysis. This objective measure was accompanied by high (>90%) GAIS responder rates and improvements from baseline in mean score on the FACE-Q Satisfaction with Chin module and FACE-Q Satisfaction with Lower Face and Jawline scale at Month 3.¹⁷ A retrospective analysis of patients undergoing aesthetic improvement to facial contour with VYC-25L in the nose, chin, and jawline (n = 67) or in the chin and jawline only (n = 24), or in the nose only (n = 44) also found substantial improvements from baseline in key nasal angles and chin projection measurements with 3D image analysis.³⁴

Subgroup analyses showed similarly high proportions of treated participants who met primary and key secondary effectiveness endpoints regardless of skin type, gender, or age group, attesting to the generalizability of these results to a diverse population. VYC-25L was safe and effective for jawline restoration regardless of whether participants were male, female, baby boomers, millennials, generation X’ers, or people of diverse Fitzpatrick skin types. These results contribute to the current literature by demonstrating the effectiveness of an HA filler in diverse populations, which is informative considering the increase in aesthetic procedures, including fillers, among people with skin of color, and younger individuals (such as millennials), as well as the growing use of fillers in males, possibly reflecting the key role of jawline appearance in male aesthetic preferences.^{11,12,14,29,35,36}

As previously reported, VYC-25L was well tolerated with minimal procedural pain.¹⁸ The most common ISRs (tenderness to touch, lumps/bumps, and pain after injection) were not unexpected based on previous studies.^29,37,38 Incidence of ISRs in subpopulations was similar to that in the overall safety cohort, although a greater proportion of females reported having an ISR compared to males. The smaller male cohort of this study may have affected the reported differences in ISR incidence rates. Similarly, females had slightly higher FACE-Q Satisfaction with Lower Face and Jawline score improvements than males through Month 9, also indicating that the male sample size may have had an impact on results. However, the lower percentage of male participants included in this study, 12.6% (26/206), is reflective of clinical practice. The 2020-2021 Aesthetic Plastic Surgery National Databank Statistics showed that males received only 4.3% of all nonsurgical aesthetic procedures and 3.7% of all dermal injections performed in the United States in 2021.¹⁰

A limitation of this study was that participants were not blinded to treatment received. However, mitigating against potential bias are that participant self-assessments were conducted only in treated participants (ie, the treatment group and control participants who opted for treatment after Month 6) and concordance between participant- and blinded investigator–assessed GAIS responder rates was observed. Another limitation was a potential for bias to occur with subjective rating scales because of reliance on the interpretive judgments of the evaluators; however, the validated assessments (ie, ALJDS and FACE-Q) in this study provide support that the results are clinically meaningful, valid, and reliable. Finally, ALJDS assessments were conducted based on photographs, not on the appearance of live participants, and therefore relied on the image collection methodology. Consistency in image collection (eg, lighting, head position, and facial expressions) is particularly important in aesthetic image assessments.^39,40 Therefore, the photograph assessments for the ALJDS responder assessment may have had an impact on the ALJDS responder rate in the control group.

CONCLUSIONS

In this registration study, both objective and subjective measures were employed to establish the safety and effectiveness of VYC-25L injections for restoration of moderate or severe loss of jawline definition for up to 12 months, with high participant satisfaction, improvements in jawline profile, and a similar effect across skin phototype, age, and gender. The results of the current study, considered together with previously published participant satisfaction data, support the role of VYC-25L as an effective and safe treatment for improving jawline definition and restoring jawline volume in patients seeking to improve the appearance of their jawline and lower face.

Supplemental Material

This article contains supplemental material located online at www.aestheticsurgeryjournal.com.

Disclosures

Dr Burgess received an Allergan (Irvine, CA)/AbbVie (North Chicago, IL) clinical research grant and is on the advisory board. Dr Dayan is a researcher, speaker, and consultant for AbbVie, Merz (Frankfurt, Germany), Galderma (Lausanne, Switzerland), Teoxane (Geneva, Switzerland), and Revance (Nashville, TN). Dr Bank is an investigator for Allergan Aesthetics, an AbbVie company. Dr Weinkle is a clinical investigator for Allergan and participated in the Volux study. Dr Sartor and Dr Chawla are full-time employees of AbbVie and own AbbVie stock. Dr Keaney is a speaker, consultant, advisory board member, and investigator for Allergan.

Funding

Allergan Aesthetics, an AbbVie company (Irvine, CA), funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.