Improvement in Temple Hollowing with VYC-20L Hyaluronic Acid Filler: A Multicenter Randomized Controlled Trial of Safety and Effectiveness

Abstract

Background:

Temple hollowing is characterized by a reduction of volume in the temporal fossa, which can result in a skeletonized look and contribute to an aged appearance. This study aimed to evaluate the safety and effectiveness of VYC-20L injectable gel to improve temple hollowing.

Methods:

Adults with minimal, moderate, or severe temple hollows were randomized 2:1 to receive VYC-20L or no treatment. Participants were followed up for 13 months for safety and effectiveness assessments. Treatment effectiveness was assessed by blinded evaluating investigators using the validated Allergan Temple Hollowing Scale (ATHS) and the Global Aesthetic Improvement Scale (GAIS), and by participants using GAIS, FACE-Q scales, and patient satisfaction questionnaires. Adverse events and injection-site responses were monitored.

Results:

At month 3, 80.4% of the treatment group versus 13.5% of the untreated control group achieved a 1-grade improvement or greater in both temples on the ATHS (P < 0.0001). The ATHS responder rate remained high throughout month 13. The GAIS responder rates at month 3 (responses of improved or much improved) were high in the treatment group, as assessed by the blinded evaluating investigator (83.8%) and participants (92.9%). Furthermore, satisfaction with facial appearance and temples on the FACE-Q questionnaires increased significantly from baseline (both P < 0.0001). Adverse events and injection-site responses were mostly mild and consistent with the known safety profile of fillers.

Conclusions:

VYC-20L treatment showed favorable safety and effectiveness results in restoring temple volume, with significant aesthetic improvement and high participant satisfaction. Treatment effects lasted for more than a year.

CLINICAL QUESTION/LEVEL OF EVIDENCE:

Therapeutic, II.

Temple hollowing refers to loss of volume in the temporalis muscle and temporal fat pad, resulting in the emergence of bony margins, leading to a gaunt and skeletonized appearance.^1–4 Temple hollowing is commonly associated with aging, but can also occur in thin or athletic individuals, in patients with human immunodeficiency virus and antiretroviral lipoatrophy, or as a consequence of a coronal incision.^4–6 Various treatments have been explored to address temple hollowing, including fat grafting, surgical implants, and soft-tissue fillers, such as hyaluronic acid (HA), poly-L-lactic acid, and calcium hydroxylapatite.^1,7,8 HA-based soft-tissue fillers have become an established treatment option because they provide immediate and natural results, and are considered safe.^3,4,7 In addition, their effects can be reversed by hyaluronidase.^4,9

VYC-20L (Juvéderm Voluma XC; Allergan Aesthetics, an AbbVie company) is an HA soft-tissue filler with lidocaine that is well suited for volumizing and contouring in facial rejuvenation given its high viscosity and cohesivity.¹⁰ Previous studies have demonstrated that VYC-20L is well tolerated and can effectively improve temple hollowing.^11–15 However, these studies had limitations, such as being uncontrolled, single-center, or open-label, or having small sample sizes. Further research with a more rigorous study design is required to establish the safety and effectiveness of VYC-20L for temple hollowing treatment. This multicenter, evaluator-blinded, randomized, controlled, parallel-design pivotal study was designed to assess the safety and effectiveness of VYC-20L in improving temple hollowing.

PATIENTS AND METHODS

Study Design

This study was conducted at 15 sites in the United States in accordance with all applicable international guidelines. It was reviewed and approved by an institutional review board, and all participants provided informed consent before study initiation.

Randomization and Treatment

Eligible participants were randomly assigned in a 2:1 ratio to VYC-20L or no treatment (control) based on a central randomization schedule. Participants in the treatment group received VYC-20L on day 1 and an optional touch-up treatment after 30 days, and were followed up at day 3, day 14, and months 1, 3, 6, 9, and 13 after the last treatment. Participants in the control group did not receive any treatment and were followed up for 3 months. At that time, they were given the option to exit the study or receive treatment (initial treatment and touch-up if necessary) with the same follow-up schedule as the treatment group. A subset of participants from the treatment group received repeated treatment after the month 13 visit and were followed up for 6 months.

VYC-20L was injected in bolus using 27-G half-inch or 25-G 1-inch needles in the supraperiosteal plane in the temples using the 1-up-and-1-over technique.¹⁶ The injection location was approximately 1 cm inferolaterally to the temporal fusion line and 1 cm superolaterally to the lateral orbital rim (Fig. 1). The maximum permitted injection volume was 3 mL/temple for the combined initial and touch-up treatments, with a limit of 2 mL/temple per treatment session.

Fig. 1.

Injection site. The injection site is situated at approximately 1 cm superior and 1 cm lateral to where the temporal fusion line meets the lateral orbital rim.

Participants

Eligible male and female participants 22 years or older who exhibited minimal, moderate, or severe hollows in both temples were randomized. Participants with temple hollowing due to trauma, congenital malformations, or lipodystrophy; temporomandibular joint dysfunction or any other jaw issues; recurrent temporal headaches; active immune disease; or a history of allergy or anaphylaxis to lidocaine were excluded. In addition, participants who had undergone previous facial reconstructive surgery, face lift or brow lift, or surgery on the temple area (e.g., biopsy), or had received fat injections or permanent facial implants, semipermanent soft-tissue filler treatment in the temple or midface within 36 months before enrollment, temporary dermal filler treatment above the subnasale within 24 months before enrollment, or botulinum toxin injections, mesotherapy, or other cosmetic procedures above the subnasale within 6 months before study enrollment were deemed ineligible for the study.

Assessments

Effectiveness

The primary end point was the Allergan Temple Hollowing Scale (ATHS) responder rate at month 3. A responder was defined as a participant with at least 1-grade improvement from their baseline ATHS score in both temples, based on the blinded evaluating investigator’s (EI) live assessment. The ATHS is a validated 5-point scale with substantial intrarater agreement (mean weighted kappa, 0.86) and interrater agreement (intraclass correlation coefficient, 0.81). A 1-point difference on the ATHS scale indicated a clinically significant change in temple volume deficit.¹⁷

Secondary end points included the Global Aesthetic Improvement Scale (GAIS) responder rate at month 3, as assessed by both the blinded EI and the participant. The GAIS responder rate was defined as the proportion of participants with a rating of improved or much improved in overall temple area aesthetics compared with baseline images using the 5-point GAIS (2 = much improved; 1 = improved; 0 = no change; −1 = worse; −2 = much worse). Other secondary end points were the change from baseline on the FACE-Q Satisfaction with Facial Appearance questionnaire at month 3 and the change from baseline on the FACE-Q Satisfaction with Temples questionnaire at month 3. The 10-item FACE-Q Satisfaction with Facial Appearance questionnaire and multiple-item FACE-Q Satisfaction with Temples questionnaire are validated 4-point scales, where 1 = very dissatisfied and 4 = very satisfied.^18–20 Other effectiveness analysis included temple volume change using 3-dimensional image volumetric analysis and the participant’s satisfaction with treatment.

Safety

Safety assessments included analysis of adverse events (AEs) and vision (Snellen visual acuity, confrontational visual fields, and ocular motility), which were monitored by the treating investigator at all study visits. Participants rated procedural pain (during injection) immediately after the initial and touch-up treatments on an 11-point scale, with 0 indicating no pain and 10 the worst imaginable pain. Participants also recorded injection-site responses (ISRs) in an e-diary for 30 days after the initial treatment and 14 days after touch-up and repeated treatments. In addition, participants assessed their jaw function with the 20-item Jaw Functional Limitation Scale.

Statistical Analysis

A total of 90 participants in the treatment group and 45 in the control group were estimated to provide 90% or greater power to detect a difference of 30% between groups for the primary end point responder rates. The analyzed populations included the modified intent-to-treat population, consisting of all randomized participants who had nonmissing ATHS assessment at baseline (n = 171), and the safety population, consisting of all randomized participants who had 1 or more study treatment interventions (n = 171).

For the primary end point, ATHS responder rates were compared between treatment and control groups using a 2-sided Fisher exact test. A P value less than 0.05 was considered statistically significant. The change from baseline to month 3 on the FACE-Q questionnaires was evaluated with a 2-sided paired t test at a significance level of 5%. The primary and secondary analysis at timepoints different from the primary timepoint (month 3) and all other variables were summarized descriptively, as were demographic and safety data. Statistical analyses were conducted using SAS version 9.4 (SAS Institute, Inc.).

RESULTS

Participants

Of 205 participants screened, 171 were randomized to VYC-20L (n = 113) or no treatment control (n = 58). (See Table, Supplemental Digital Content 1, which summarizes the study participant disposition, http://links.lww.com/PRS/H715.) Of the 171 participants randomized, 162 (94.7%) completed the primary end point visit and 140 (81.9%) completed the study. No participant withdrew because of AEs.

The study included participants ranging in age from 25 to 82 years, with a mean age of 54.9 years in the treatment group and 54.4 years in the untreated control group. Most participants were women (83.6%) and White (83.0%). The demographic and baseline characteristics of the 2 groups were balanced (Table 1).

Table 1.

Demographic and Baseline Characteristics of Participants in the Modified Intent-to-Treat Population

Characteristics	Control (n = 58)	VYC-20L (n = 113)	Total (n = 171)
Age, yrs, mean ± SD	54.4 ± 9.81	54.9 ± 9.97	54.7 ± 9.89
Sex, no. (%)
Male	11 (19.0)	17 (15.0)	28 (16.4)
Female	47 (81.0)	96 (85.0)	143 (83.6)
Race, no. (%)
American Indian or Alaskan Native	0 (0.0)	1 (0.9)	1 (0.6)
Asian	1 (1.7)	2 (1.8)	3 (1.8)
Black or African American	6 (10.3)	12 (10.6)	18 (10.5)
Native Hawaiian or Other Pacific Islander	0 (0.0)	0 (0.0)	0 (0.0)
White	48 (82.8)	94 (83.2)	142 (83.0)
Multiplea	3 (5.2)	4 (3.5)	7 (4.1)
Ethnicity, no. (%)
Hispanic	14 (24.1)	27 (23.9)	41 (24.0)
Not Hispanic	44 (75.9)	86 (76.1)	130 (76.0)
Fitzpatrick skin phototype, no. (%)
1 or 2	20 (34.5)	39 (34.5)	59 (34.5)
3 or 4	34 (58.6)	60 (53.1)	94 (55.0)
5 or 6	4 (6.9)	14 (12.4)	18 (10.5)

^aBlack or African American and White.

Treatment Administration

Anesthesia (ice, topical, or local, or a combination) was administered to 43.8% of participants, with the majority (38.4%) receiving topical anesthesia. In the treatment group, 112 participants received initial treatment, 73 (65.2%) received an additional touch-up treatment, and 40 (35.7%) received a repeated treatment. The most common reason for participants not receiving repeated treatment was that full correction remained. The median total volume injected for both temples in the treatment group was 3.65 mL for initial and touch-up treatments combined and 2.0 mL for repeated treatment. All injections were administered in boluses into the supraperiosteal plane, and most were performed using a 27-G half-inch needle.

Effectiveness

ATHS Responder Rate

Temple hollowing significantly improved at month 3 in the treatment group compared with the untreated control group according to EI assessment using the ATHS. The ATHS responder rate was 80.4% (95% CI, 72.7% to 88.1%) for the treatment group versus 13.5% (95% CI, 4.5% to 22.5%) for the untreated control group (P < 0.0001) (Fig. 2).

Fig. 2.

Proportion of responders (1 grade or greater improvement from baseline on the ATHS in both temples) over time based on blinded EI live assessment. Error bars indicate 95% confidence intervals. *P < 0.0001 versus untreated control.

VYC-20L effects were visible from month 1 and lasted for more than 1 year. At month 1, the percentage of ATHS responders was 81.7% (95% CI, 72.9% to 88.6%) in the VYC-20L group versus 23.6% (95% CI, 13.2% to 37.0%) in the untreated controls. The ATHS responder rate with VYC-20L was 73.3% (95% CI, 63.0% to 82.1%) at month 13. Images of participants before and after 3 and 13 months of VYC-20L treatment can be seen in Figure 3.

Fig. 3.

Representative photographs of improved temple hollowing after VYC-20L treatment. A participant with a baseline ATHS score of 4 (severe) on both temples (above, left) received 1.0 mL/temple at initial treatment and 1.0 mL/temple at touch-up treatment, and had a score of 0 (convex) on both temples at month 3 (above, center) and maintained these results through month 13 (above, right). A participant who had a baseline ATHS score of 4 on both temples (center, left) received 1.0 mL/temple at initial treatment and 1.0 mL/temple at touch-up treatment, and had a 3-point ATHS improvement (from severe to flat) at month 3 (center) and reached a score of 2 (minimal) on both temples at month 13 (center, right). A participant with an ATHS score of 3 (moderate) on both temples (below, left) had a score of 2 on the left temple and 1 on the right temple at month 3 (below, center) and a score of 0 on the left temple and 1 on the right temple at month 13 (below, right). The initial treatment consisted of 1.0 mL/temple; during touch-up, the participant received 0.3 mL on the left temple and 0.6 mL on the right temple.

For participants who received repeated treatment, 77.5% (95% CI, 61.5% to 89.2%) were ATHS responders at month 3 and 57.5% (95% CI, 40.9% to 73.0%) were responders at month 13. After repeated treatment, the responder rate increased to 82.9% (95% CI, 66.4% to 93.4%) and remained high up to 6 months later (71.4%; 95% CI, 53.7% to 85.4%).

Global Aesthetic Improvement

The EIs rated 83.8% of participants (95% CI, 75.3% to 90.3%) in the treatment group as improved or much improved on the GAIS at month 3 versus 10.7% in the untreated control group (95% CI, 4.0% to 21.9%) (Fig. 4). At month 13, 72.2% of participants (95% CI, 61.8% to 81.1%) continued to have improved or much improved global aesthetic appearance.

Fig. 4.

Proportion of participants with an improved or much improved global aesthetic appearance, as assessed by the blinded EI and participants over time using GAIS. Error bars indicate 95% confidence intervals.

According to the participants, the GAIS responder rate at month 3 for the treatment group was substantially better (92.9%; 95% CI, 86.0% to 97.1%) compared with the untreated control group (2.0%; 95% CI, 0.0% to 10.4%) (Fig. 4). By month 13, 78.9% (95% CI, 69.0% to 86.8%) of treated participants continued to report improved or much improved global aesthetic appearance on the GAIS.

Satisfaction with Facial Appearance and Temples (FACE-Q)

The FACE-Q Satisfaction with Facial Appearance overall Rasch-transformed mean score improved significantly by a mean of 24.2 points (95% CI, 19.7 to 28.6) from baseline to month 3 (P < 0.0001) in the treatment group, whereas the untreated control group worsened by −6.6 points (95% CI, −9.1 to −4.1) (Fig. 5, above). The Rasch-transformed mean score remained high through month 13 compared with baseline (20.3; 95% CI, 15.8 to 24.7).

Fig. 5.

FACE-Q Satisfaction with Facial Appearance questionnaire results. (Above) Overall Rasch-transformed mean score (100-point scale; higher scores indicate more favorable outcomes). (Below) Proportion of participants who reported being satisfied (somewhat satisfied to very satisfied) before and after treatment with VYC-20L in key individual items. Error bars indicate 95% confidence intervals. *P < 0.0001 versus baseline.

Improvements were also seen in individual FACE-Q Satisfaction with Facial Appearance questions. At month 3, participants in the treatment group showed increased satisfaction with facial symmetry and balance, with 89.0% and 88.0% expressing satisfaction (somewhat satisfied to very satisfied), respectively, compared with 54.0% and 49.6% at baseline. There was also a notable increase in satisfaction with fresh appearance, profile view, appearance in photographs, and appearance under bright light, with at least 40% more participants reporting satisfaction at month 3 compared with baseline. Even at month 13, 62% or more of participants remained satisfied with each of these aspects (Fig. 5, below).

The FACE-Q Satisfaction with Temples overall Rasch-transformed mean score improved significantly by a mean of 42.7 points (95% CI, 37.4 to 48.0) from baseline to month 3 (P < 0.0001) in the treatment group; the untreated control worsened by −4.2 points (95% CI, −8.3 to −0.0) (Fig. 6, above). The Rasch-transformed mean score remained high through month 13 compared with baseline (34.1; 95% CI, 28.7 to 39.6).

Fig. 6.

FACE-Q Satisfaction with Temples questionnaire results. (Above) Overall Rasch-transformed mean score (100-point scale, where higher scores indicate more favorable outcomes). (Below) Proportion of participants who reported being satisfied (somewhat satisfied to very satisfied) before and after treatment with VYC-20L in key individual items. Error bars indicate 95% confidence intervals. *P < 0.0001 versus baseline.

Individual responses to the FACE-Q Satisfaction with Temples questionnaire showed that at month 3, 83.7% of the treatment group were satisfied with the youthful appearance of their temples, compared with 13.5% at baseline. Satisfaction also increased in other areas, such as how well the temples fit with the rest of their face, with 85.7% expressing satisfaction at month 3 compared with 28.8% at baseline. In addition, there was an increase in satisfaction for other aspects of temple appearance, with at least 52% more of participants expressing satisfaction from baseline to month 3. More than 73% remained satisfied with these aspects at month 13 (Fig. 6, below).

Other Exploratory Outcomes

When examining volumetric changes, the treatment group exhibited a mean increase from baseline of 1.1 cc/temple and 0.8 cc/temple at months 1 and 6, respectively. At month 13, the mean volume increase from baseline was 0.8 cc in the right temple and 0.7 cc in the left temple. In addition, participants reported satisfaction with treatment. At month 3, 91.0% of treated participants reported being satisfied or very satisfied with the overall result of treatment, 89.0% with how natural the temple area looked, and 91.0% with how natural the temple area felt; 87.0% reported the treatment met expectations, 93.0% were likely to continue treatment, and 98.0% were willing to recommend treatment. Satisfaction remained high in the treatment group throughout month 13 (Fig. 7).

Fig. 7.

Participant satisfaction with treatment.

Safety

Participants in the treatment group rated procedural pain as minimal, with mean scores of 1.3 for initial treatment and 1.0 for touch-up treatment. For ISRs, 95 participants (59.0%) reported at least 1 ISR after initial treatment, 46 (42.6%) after touch-up, and 17 (42.5%) after repeated treatment. The most frequently reported ISRs after initial treatment were pain after injection (50.9%), tenderness to touch (49.7%), and redness (41.0%) (Table 2). Common ISRs were the same after repeated treatment with lower incidence rates. Most ISRs were mild or moderate in severity after all treatments (initial, touch-up, or repeated) and resolved within 1 week of injection.

Table 2.

ISRs after Initial Treatment Reported by More Than 5% of Treated Participants with Recorded Responses on the E-Diaries (n = 161)^a

Injection-Site Response	Total Incidence	Mild	Moderate	Severe
Any	95 (59.0)	67 (41.6)	25 (15.5)	3 (1.9)
Pain after injection	82 (50.9)	61 (37.9)	18 (11.2)	3 (1.9)
Tenderness to touch	80 (49.7)	69 (42.9)	9 (5.6)	2 (1.2)
Redness	66 (41.0)	55 (34.2)	9 (5.6)	2 (1.2)
Firmness	61 (37.9)	54 (33.5)	6 (3.7)	1 (0.6)
Swelling	49 (30.4)	42 (26.1)	7 (4.3)	0 (0.0)
Lumps or bumps	42 (26.1)	37 (23.0)	5 (3.1)	0 (0.0)
Bruising	26 (16.1)	24 (14.9)	2 (1.2)	0 (0.0)
Discoloration	11 (6.8)	9 (5.6)	2 (1.2)	0 (0.0)

^aData are presented as no. (%).

Treatment-related AEs occurred in 29 participants (17.6%), which were mostly mild. The most common AEs included jaw pain (6.1%) and headache (4.8%) (Table 3). The majority of treatment-related AEs resolved within 1 week. Four participants experienced treatment-related AEs that resolved after 30 days: mild trismus (decrease in jaw function when yawning), which lasted for 42 days; mild injection site mass, which lasted for 56 days; mild injection site pain, which lasted for 32 days; and mild injection site mass, which lasted for 66 days. All resolved without intervention or sequalae. Of the 40 participants who received repeated treatment, 5 (12.5%) experienced treatment-related AEs. All these treatment-related AEs were mild and resolved without intervention or sequalae.

Table 3.

Treatment-Related AEs Occurring in More Than 1% of Treated Participants (n = 165)

Treatment-Related AE	Treated Participants, No. (%)
Pain in jaw	10 (6.1)
Headache	8 (4.8)
Injection site pain	3 (1.8)
Injection site discomfort	2 (1.2)
Injection site mass	2 (1.2)
Temporomandibular joint syndrome	2 (1.2)
Trismus	2 (1.2)

There were no serious treatment-related AEs, late-onset AEs (AEs started over 4 weeks from treatment), AEs leading to study discontinuation, AEs related to vascular occlusion, or deaths.

Other Safety Assessments

No significant changes were found in the Jaw Functional Limitation Scale overall score between baseline and all subsequent timepoints, including subscores for mastication, mobility, and verbal and nonverbal communication. Furthermore, the Snellen visual acuity test revealed no clinically meaningful changes in participants’ vision after treatment, and there were no differences in confrontational visual fields or ocular motility after treatment.

DISCUSSION

A wide range of soft-tissue fillers is available, each with distinct rheologic properties that make them appropriate for specific indications. VYC-20L uses a unique combination of high- and low-molecular-weight HA polymers, resulting in a filler with high viscosity and cohesivity. These properties confer VYC-20L with high lifting capacity, which is well suited for deeper injections, with minimal polymer volume changes after injection.^10,21 In addition, the tight HA network provides increased resistance to degradation, leading to longer-lasting results.²²

The effects of VYC-20L were observed as early as month 1 and persisted for more than a year. At the month 3 primary end point, the VYC-20L treatment group responder rate was 80.4% (P < 0.0001 versus the untreated control group). The positive effects of VYC-20L were further corroborated by the secondary end points, which showed improvements in EI- and participant-assessed GAIS and FACE-Q scores. In addition, participants expressed satisfaction with treatment outcomes, including the natural appearance and feel of their temples. These results align with the medical literature on VYC-20L for temple volume restoration and demonstrate the effectiveness of the treatment in improving temple hollowing.^11,13 This study strengthens the existing research by incorporating a control group, larger sample size, validated severity scales, and patient-reported outcomes specifically designed for the temple area.

In the study, VYC-20L was injected deep into the supraperiosteal plane 1 cm superior and 1 cm lateral to where the temporal fusion line meets the lateral orbital rim. Most injections were performed with a 27-G half-inch needle. When injecting into the temple, it is crucial to exercise caution to prevent any damage to the superficial temporal artery and vessels, as well as the middle temporal vein, medial zygomaticotemporal vein, and deep temporal arteries.^1,23–27 A comprehensive understanding of the anatomy of the temple area, including awareness of the substantial variation in facial arterial vasculature among individuals,²⁸ is essential. A deep supraperiosteal injection may reduce the risk of intravascular injection and minimize the potential for nerve or blood vessel injury, as these structures are more superficial in the temporal fossa. By using the injection window described here, the middle temporal vein, which has been linked to vision complications, can be avoided.¹ Although other injection techniques have been proposed,^29–32 this injection method has been endorsed by field experts and the American Society for Dermatologic Surgery.^{1,16,23,24,33} A diagram of the safe temple injection zone, highlighting critical vasculature, can be found in Carruthers et al.²³ Before injection, palpation and visual inspection of the superficial temporal artery and its branches are recommended to further enhance the safety and precision of temple volumization.¹ Administering the product slowly and steadily is also key to avoid complications.¹

This deeper injection may require a larger filler volume compared with a shallower injection. Cotofana et al.³⁴ observed that when injecting 0.5 mL of soft-tissue filler into the sub–orbicularis oculi fat compartment, 94% of the volume resulted in skin projection. However, when injecting the same amount in the deep temporal fat pad, only 53% led to visible changes. The median volume used in the study was 3.65 mL for both temples for the initial (and touch-up) treatment and 2.0 mL for repeated treatment.

The safety profile of VYC-20L for this indication was consistent with previous studies of VYC-20L and other HA fillers in temple hollowing.^{6,11,15,35,36} Procedural pain was rated as minimal. Most ISRs were mild or moderate and resolved within a week. The most common treatment-related AEs after initial or touch-up treatment were headache and jaw pain, which resolved within 5 days. Filler injections in the temples can exert pressure on muscles associated with jaw function, such as the temporalis and masseter, which run through or connect at this region. This may result in jaw pain or discomfort while chewing, which generally resolves within a few days.^11,35,37

The effects of VYC-20L remained 13 months after the initial treatment. However, longer-term studies are needed to evaluate the sustained efficacy and safety of VYC-20L for improvement of temple hollowing. Our study mainly included White female participants, but the diversity in our sample is consistent with the demographic representation of patients who typically receive temple treatment in clinical practice. According to the 2020 Plastic Surgery Statistics Report from the American Society of Plastic Surgeons, 4%, 5%, and 10% of all soft-tissue filler injections in the United States were performed on male, Black, or Hispanic patients, respectively.³⁸ In addition, an AbbVie-sponsored online survey conducted from December of 2022 to January of 2023 in the United States involving 200 health care professionals who had a minimum of 2 years of dermal filler injection experience showed that 17%, 9%, and 10% of temple filler injections were performed on male, Black, or Hispanic patients, respectively (unpublished data). Another limitation of the study is the lack of 2-dimensional photographs. During the rendition from 3-dimensional to 2-dimensional images, areas such as hair and ears were cropped, and dimensional data were reduced. Nevertheless, the rendered images reflect the findings of the study accurately.

CONCLUSIONS

VYC-20L was found to be safe and effective in improving temple hollowing, with immediate and long-lasting results, which persisted for more than a year. Repeated treatment resulted in comparable outcomes with approximately half of the injection volume. Participants treated with VYC-20L were highly satisfied with the treatment outcome and would recommend the treatment to a friend more than 1 year after treatment.

DISCLOSURE

Dr. Montes and Dr. Yoelin are consultants, investigators, speakers, and trainers for Allergan Aesthetics, an AbbVie company. Dr. Hooper and Dr. Biesman are investigators, consultants, and advisory board members for Allergan Aesthetics, an AbbVie company. Dr. Jones is an investigator, consultant, or advisory board member for Allergan Aesthetics, an AbbVie company, and Galderma. Dr. Baumann is an investigator for Allergan Aesthetics, an AbbVie company, Teoxane, and Galderma, and a consultant for AbbVie. Dr. Beer is an investigator and consultant for AbbVie. Drs. Leung and Chawla are employees of Allergan Aesthetics, an AbbVie company, and may own AbbVie stock.

ACKNOWLEDGMENTS

Allergan Aesthetics, an AbbVie company, and the authors thank the study and site investigators, coordinating staff, and participants involved in this trial. Allergan Aesthetics, an AbbVie company, funded this study and participated in the study design, research, analysis, data collection, interpretation of data, review, 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. Medical writing support was provided by Ana Vicente-Sanchez, PhD, of AbbVie Inc., and editorial support was provided by Angela T. Hadsell of AbbVie Inc.; both were funded by AbbVie Inc.

DATA SHARING STATEMENT

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