Abstract
In an evaluator-blinded, randomized controlled trial, the hyaluronic acid soft-tissue filler VYC-20L injectable gel was safe and effective for correcting volume deficits and retrusion in the chin.
The objective of this subanalysis was to compare responder rates obtained with photographic vs live assessments.
Participants were randomized 3:1 to VYC-20L treatment or a 6-month, no-treatment control period followed by optional treatment. Responder rates (≥1-point improvement from baseline on the validated Allergan Chin Retrusion Scale [ACRS]) obtained with photographic assessments and live assessments at Month 6 were compared. Prespecified subgroup analyses compared responder rates by baseline ACRS severity, filler volume, cannula usage, and investigation site.
VYC-20L was effective for chin augmentation as evaluated with both live and photographic assessments. The ACRS responder rates at Month 6 were 91.8% with live assessments and 56.3% with photographic assessments. Consistently higher response rates were observed by live vs photographic assessment regardless of baseline ACRS severity, filler volume, cannula usage, and investigation site.
Live assessment of ACRS response after VYC-20L treatment resulted in higher responder rates than photographic assessment, supporting the use of live assessment for this indication to approximate real-world clinical practice.
Chin shape and projection contribute to overall facial harmony, balance, and perceptions of attractiveness.1 The effects of congenital elements and aging on facial appearance may prompt some individuals to seek minimally invasive treatments, such as soft tissue fillers, to correct or rejuvenate the chin region.1 Soft tissue fillers are often employed to correct volume deficits in the mid- and lower face, including treatment of moderate to severe chin retrusion.2-4
Results of a multicenter, evaluator-blinded, randomized, controlled premarketing study of VYC-20L (Juvéderm® Voluma™ XC, Allergan Aesthetics, an AbbVie Company, Irvine, CA) in adults seeking chin augmentation to correct volume deficit and retrusion demonstrated its safety and effectiveness, with results lasting through 1 year.3 At Month 6, more than half of the participants (56.3%) treated with VYC-20L achieved the primary endpoint, a ≥1-point improvement on the validated Allergan Chin Retrusion Scale (ACRS; Figure 1A), vs 27.5% in the no-treatment control group as assessed by blinded evaluating investigators (EIs) with 2-dimensional (2D) renderings from 3-dimensional (3D) images (photographic assessment) of the chin (Figure 1B-D).3
(A) Allergan Chin Retrusion Scale (ACRS) for photographic assessment of participant chin retrusion scores. A schematic illustration of rendering of a 2D image from a 3D participant image is shown as follows: (B) The 3D image is registered to the center of a 3D grid following the Frankfort plane orientation. The registered 3D image could be rotated to fixed views in 3D space (Appendix, available online at www.aestheticsurgeryjournal.com). (C) The view of the 3D image is rotated to the participant's left profile. The software adds a fixed millimeter scale to the 3D space at a fixed position in the grid, then creates a 2D image of fixed side. A crop box (black box) is placed on the bottom of the 2D image and adjusted horizontally to approximately center the chin within the frame. (D) The image is cropped to create the final 2D image for the evaluating investigator to assess. 2D, 2-dimensional; 3D, 3-dimensional. *Chin midpoint: the midpoint between the labiomental sulcus and the inferior point of the chin. Panel A Reproduced with permission from Sykes et al., 2016.5
In clinical studies, photographs are commonly utilized in conjunction with photonumeric rating scales to assess posttreatment aesthetic improvements.6,7 Although photonumeric scales are often employed as subjective effectiveness measures, application by a blinded investigator may limit bias to support the approval of a soft tissue filler product. Improvements from baseline are rated by blinded investigators either live or with photographs.8 The ACRS was designed to evaluate the horizontal projection of the chin and was validated in a study that used profile/lateral photographs, making it well suited for clinical photographic assessment.5 However, the chin is a 3D structure that can be assessed horizontally, vertically, and transversely; therefore chin contour, shape, depth, and volume can also affect how it is evaluated and perceived aesthetically.5
Improving patient satisfaction and projecting a favorable first impression are important clinical goals in the field of aesthetic medicine.9,10 Furthermore, the application of global and integrated treatment approaches that consider interrelationships among facial areas has become increasingly widespread.10,11 Unlike photographic assessments, live assessments approximate what occurs in real-world clinical practice, in which the clinician/investigator can assess the effects of a specific treatment holistically, in the context of the entire face and individual. Few studies have compared photographic and live assessments after filler treatment to determine potential differential effects of the assessment procedure on numeric rating scale scores assigned by the blinded EI.12,13
In the VYC-20L trial, ACRS data from both photographic and live investigator assessments were collected at Month 6; therefore, a comparison of the results obtained with both approaches was possible. The current analysis compared changes from baseline in chin retrusion following treatment with VYC-20L, evaluated with live assessments vs photographic assessments of the chin at Month 6. Analyses were also performed to compare live assessments and photographic assessments across different participant subgroups.
METHODS
Study Design
Full details of the study methods have been described elsewhere.3 Briefly, this randomized, evaluator-blinded, delayed-treatment, controlled study was conducted at 14 sites in the United States between June 2016 and October 2018 (NCT02833077). Each study site received institutional review board approval from either Quorum Review IRB (Seattle, WA) or St. Louis University IRB (St. Louis, MO). The study was conducted in compliance with the International Conference on Harmonisation guidelines on good clinical practice. Participants provided written informed consent at screening and were randomized in a 3:1 ratio to the VYC-20L treatment group (with optional touch-up and optional retreatment at 30 days and 12 months, respectively, following initial treatment) or to the no-treatment control group (with optional treatment/touch-up treatment delayed by 6 months) based on a central randomization schedule. An automated interactive web response system managed the randomization and treatment assignment based on a randomization scheme prepared by Allergan.
Participants
Enrollment targeted adults aged 22 years and older with moderate or severe chin retrusion (grade 2 or 3) on the 5-point photonumeric ACRS, as determined by the EI and the treating investigator (TI).5 Individuals were excluded from enrollment if they had clinically significant malocclusion, dentures, or any other device that would interfere with assessment of the chin area, or had undergone aesthetic facial plastic surgery, tissue grafting, or other tissue augmentation procedures, including toxin and filler injections, within a specified washout period several months previous to enrollment (36 months for semipermanent dermal filler treatment in the chin or jaw; 24 months for dermal filler injections in the chin or jaw area—including marionette lines, prejowl sulci, mandibular body, or masseter muscles; and 12 months for dermal filler injections in the lips or perioral area) or had planned to undergo any of these procedures during the study.
Treatments
VYC-20L was injected by a TI with a 27-gauge 0.5-inch needle for supraperiosteal and/or subcutaneous injections into the pogonion; optional use of a 25-gauge 1.5-inch cannula was permitted for supraperiosteal and/or subcutaneous injections in the menton and prejowl sulci. The maximum total volume of VYC-20L could not exceed 4 mL for initial and touch-up treatments combined. Follow-up visits occurred 1, 3, 6, 9, and 12 months following initial treatment, with Month 6 being the primary evaluation time point and the focus of the current analysis. Patients from the treatment group were followed up to 12 months post treatment and patients from the control group who opted to receive treatment (delayed by 6 months) were followed up to 6 months post treatment.
Assessments
Chin retrusion was assessed with the validated ACRS, with scores ranging from 0 (none) to 4 (extreme), by comparing the projection of the chin midpoint to 2 other anatomical areas, the labiomental sulcus and the lower vermilion border (Figure 1A).5 The primary effectiveness endpoint was ACRS responder rate (by photographic assessment), defined as the proportion of participants who showed a ≥1-point improvement on the ACRS from baseline to Month 6.
At randomization/initial therapy and during the Month 6 visit, the EI assessed the participant's chin retrusion based on the 2D rendering of the chin profile (photographic assessment) generated from 3D facial digital images (Figure 1B-D and the Appendix). Photographs ensured consistent head positioning across visits (Figure 2). To prevent bias from evaluation of the entire face and to maintain blinding of the EI, the photographs were cropped to include only the lower face (Figure 2).
Representative participant photographs. (A) The 32-year-old representative male participant had an EI-rated ACRS score of 3 (severe) at baseline and 2 (moderate) at Month 6 after treatment with VYC-20L for chin retrusion. The 43-year-old representative female participant had an EI-rated ACRS score of 4 (extreme) at baseline (B) and 2 (moderate) at Month 6 after treatment with VYC-20L for chin retrusion (C). For panels in (A) and left panels in (B) and (C), images show the 2-dimensional rendering of the chin profile generated from 3-dimensional full facial digital images. Right panels in (B) and (C) show cropped photographs that include only the lower face, evaluated by the EI to determine ACRS rating. Photographs were assessed to ensure consistent head positioning across visits. ACRS, Allergan Chin Retrusion Scale; EI, evaluating investigator.
At each site, a blinded EI performed live ACRS assessments at screening and at Month 6. The same blinded EI performed both photographic and live ACRS assessments of the same participants. Additional analyses summarized the ACRS responder rate at Month 6 by prespecified subgroups of baseline ACRS severity (minimal/moderate/severe/extreme), injection volume (≤median/>median), cannula usage (with/without), and investigation site (each of the 14 sites).
Safety
Safety, including the incidence of adverse events (AEs) and injection site responses (ISRs), was monitored during the study.
Statistical Analysis
For the effectiveness endpoint to be met, the ACRS responder rate of the treatment group was required to be statistically significantly greater (≥50%) than that of the control group at Month 6 based on a 2-sided Fisher's exact test with a 5% significance level. Data were summarized with descriptive statistics, with categorical variables summarized with frequency and percentage, and continuous variables summarized by number of participants, mean, median, standard deviation (SD), minimum, and maximum.
RESULTS
Participants
Of the 221 participants screened, 192 were randomized to the VYC-20L treatment group (n = 144) or the delayed-treatment control group (n = 48). The mean age was 49.8 years (range, 22-80), and the mean (SD) body mass index was 24.9 (4.6) kg/m2. Most participants were female (170/192, 88.5%). Most participants were White (157/192, 81.8%), with Black or African American (29/192, 15.1%), Asian (1/192, 0.5%), American Indian or Alaska Native (3/192, 1.6%), and multiracial participants (2/192, 1.0%) also represented. Over half of the participants had Fitzpatrick skin type (FST) III/IV (100/192, 52.1%); followed by FST I/II (67/192; 34.9%); and FST V/VI (25/192, 13.0%). The study was completed by 87.0% of participants; 88.2% of the treatment group completed 12 months of follow-up and 83.3% of the control group completed the 6-month no-treatment phase. Detailed demographic and baseline data were previously reported.3
The median total injection volume of VYC-20L for initial and touch-up treatments in the treatment group was 2.2 mL (range, 0.7-4.0 mL), with 1.0 mL in the pogonion, 0.5 mL in the menton, and 1.0 mL in the prejowl sulci (right and left sides combined).
Assessments
Regardless of whether photographic or live assessments were performed, participants in the VYC-20L treatment group demonstrated significantly higher ACRS responder rates at Month 6 compared with participants in the control group (photographic assessment: P = .0019; live assessment: P < .0001; Figure 3). The ACRS responder rate at Month 6 for treatment group participants was higher with live assessments than with photographic assessments (91.8% vs 56.3%, respectively; Figure 3). A greater reduction in the mean (SD) change from baseline in ACRS score at Month 6 was observed with live vs photographic assessments (−1.2 [0.6] vs −0.7 [0.9], respectively; Table 1).
(A) Month 6 ACRS responder rates with photographic assessment and (B) live assessment. ACRS, Allergan Chin Retrusion Scale.
Mean Allergan Chin Retrusion Scale (ACRS) Scores for Photographic Versus Live Assessments, as Rated by Evaluating Investigator
| ACRS score | Photographic assessment | Live assessment | ||
|---|---|---|---|---|
| Treatment (n = 144) | Control (n = 48) | Treatment (n = 144) | Control (n = 48) | |
| Baseline | ||||
| n | 144 | 48 | 144 | 48 |
| Mean (SD) | 2.5 (0.8) | 2.6 (0.7) | 2.4 (0.5) | 2.3 (0.5) |
| Month 6 | ||||
| n | 126 | 40 | 97 | 30 |
| Mean (SD) | 1.8 (1.0) | 2.5 (0.8) | 1.2 (0.6) | 2.2 (0.7) |
| Change from baseline at Month 6 | ||||
| Mean (SD) | −0.7 (0.9) | −0.2 (0.6) | −1.2 (0.6) | −0.2 (0.6) |
| ACRS score | Photographic assessment | Live assessment | ||
|---|---|---|---|---|
| Treatment (n = 144) | Control (n = 48) | Treatment (n = 144) | Control (n = 48) | |
| Baseline | ||||
| n | 144 | 48 | 144 | 48 |
| Mean (SD) | 2.5 (0.8) | 2.6 (0.7) | 2.4 (0.5) | 2.3 (0.5) |
| Month 6 | ||||
| n | 126 | 40 | 97 | 30 |
| Mean (SD) | 1.8 (1.0) | 2.5 (0.8) | 1.2 (0.6) | 2.2 (0.7) |
| Change from baseline at Month 6 | ||||
| Mean (SD) | −0.7 (0.9) | −0.2 (0.6) | −1.2 (0.6) | −0.2 (0.6) |
SD, standard deviation.
Mean Allergan Chin Retrusion Scale (ACRS) Scores for Photographic Versus Live Assessments, as Rated by Evaluating Investigator
| ACRS score | Photographic assessment | Live assessment | ||
|---|---|---|---|---|
| Treatment (n = 144) | Control (n = 48) | Treatment (n = 144) | Control (n = 48) | |
| Baseline | ||||
| n | 144 | 48 | 144 | 48 |
| Mean (SD) | 2.5 (0.8) | 2.6 (0.7) | 2.4 (0.5) | 2.3 (0.5) |
| Month 6 | ||||
| n | 126 | 40 | 97 | 30 |
| Mean (SD) | 1.8 (1.0) | 2.5 (0.8) | 1.2 (0.6) | 2.2 (0.7) |
| Change from baseline at Month 6 | ||||
| Mean (SD) | −0.7 (0.9) | −0.2 (0.6) | −1.2 (0.6) | −0.2 (0.6) |
| ACRS score | Photographic assessment | Live assessment | ||
|---|---|---|---|---|
| Treatment (n = 144) | Control (n = 48) | Treatment (n = 144) | Control (n = 48) | |
| Baseline | ||||
| n | 144 | 48 | 144 | 48 |
| Mean (SD) | 2.5 (0.8) | 2.6 (0.7) | 2.4 (0.5) | 2.3 (0.5) |
| Month 6 | ||||
| n | 126 | 40 | 97 | 30 |
| Mean (SD) | 1.8 (1.0) | 2.5 (0.8) | 1.2 (0.6) | 2.2 (0.7) |
| Change from baseline at Month 6 | ||||
| Mean (SD) | −0.7 (0.9) | −0.2 (0.6) | −1.2 (0.6) | −0.2 (0.6) |
SD, standard deviation.
Subgroup Analyses
Regardless of whether participants were assessed by the EI with photographs or live, an overall shift occurred in the proportion of participants with moderate or severe chin retrusion at baseline to minimal or moderate chin retrusion at Month 6 (Figure 4A, B). None of the participants assessed live had baseline ACRS severities of 1 (minimal) or 4 (extreme). In the treatment group, regardless of ACRS severity at baseline, the ACRS responder rate at Month 6 was consistently higher with live assessments than with photographic assessments (Figure 4C).
(A) Distribution of participants in each ACRS response category at baseline and Month 6 by photographic assessment and (B) live assessment. (C) Month 6 ACRS responder rates (treatment and control groups) with photographic assessment and live assessment by baseline ACRS category. ACRS, Allergan Chin Retrusion Scale.
Regardless of whether a participant's VYC-20L injection volume was less than or equal to or greater than the median of 2.2 mL, the ACRS responder rate at Month 6 for treatment group participants was higher with live assessments than with photographic assessments (Figure 5A). The ACRS responder rate at Month 6 for treatment group participants was also higher with live vs photographic assessments regardless of whether or not a cannula was utilized during the procedure (Figure 5B).
Month 6 ACRS responder rates with photographic assessment and live assessment by (A) median injection volume and (B) cannula usage. ACRS, Allergan Chin Retrusion Scale.
The Month 6 ACRS responder rate for treatment group participants was higher with live assessments compared with photographic assessments at 13 of the 14 investigational sites. Only 1 site (site 009) did not show this pattern, and at that site, the Month 6 ACRS responder rates appeared to be similar with live and photographic assessments (Figure 6).
(A, B) Month 6 ACRS responder rates (treatment and control groups) with photographic assessment and live assessment by study site. ACRS, Allergan Chin Retrusion Scale.
Safety
Of 182 participants treated with VYC-20L (VYC-20L treatment group participants, n = 144, and treated controls, n = 38), 14 (7.7%) participants reported treatment-related AEs after initial/touch-up treatment. The most common treatment-related AEs were injection site erythema (3/182, 1.6%) and injection site pain (3/182, 1.6%). Most were mild or moderate in severity, with the majority resolving within 1 week. Two participants (2/182, 1.1%) reported 3 severe treatment-related AEs, including injection site inflammation, injection site cellulitis, and injection site induration. All treatment-related AEs resolved without sequelae. Additional details on the safety results were previously reported.3
Of 181 VYC-20L-treated participants, 167 (92.3%) reported at least 1 ISR after initial treatment. The most common ISRs were tenderness (81.8%), firmness (75.1%), and swelling (68.5%). Most were mild or moderate in severity, with the majority resolving within 1 week. Detailed findings of the ISRs reported in this study were previously published.3
DISCUSSION
The current analysis extends the findings of the pivotal, randomized, evaluator-blinded, delayed-treatment clinical trial of VYC-20L in the chin, to demonstrate greater improvement from baseline on the ACRS in treated individuals when scored by live assessment vs 2D renderings from 3D participant images.3 Just over half (56.1%) of the treatment group participants showed a ≥1-grade improvement on the ACRS at Month 6 when rated with photographs. In contrast, most participants (91.8%) showed an improvement on the ACRS when rated in person. The higher ACRS responder rates observed with live assessment compared with photographic assessment remained consistent across several different subset analyses, suggesting that the factors of baseline ACRS severity, VYC-20L injection volume, cannula usage, and investigational site were not responsible for influencing the overall result of higher responder rates with live vs photographic assessments.
Previous studies that applied numeric rating scales to assess improvement after filler treatment support the current results.12-14 Similar to the present study that showed relatively low separation of responder rates between the treatment and no-treatment control group when photographic assessments were performed (56% vs 28%, respectively), a study describing filler treatment for jawline restoration also showed low separation in overall responder rates (participants with ≥1-point improvement in a validated jawline definition scale) between the treatment and no-treatment control groups when assessments were performed with a photonumeric scale on 3D images (69% vs 38%, respectively).14 Furthermore, similar to the present study, 2 studies in which filler treatment for lip augmentation was evaluated demonstrated lower overall responder rates (participants with 1-grade improvements in validated lip fullness scales) when assessments were performed by investigators who reviewed photographs or 3D images compared with investigators who conducted live assessments.12,13 However, unlike the present study, the analysis methods in these other studies did not include detailed subanalyses to control for potential factors that could account for differences in observed responder rates, and 1 utilized an active comparator rather than a no-treatment control group.12
The results from the ACRS live assessment align with the patient-reported outcomes (PROs) and volumetric changes measured with 3D photography previously reported from this study.3 On the Global Aesthetic Improvement Scale (GAIS), EI- and participant-assessed responder rates at Month 6 were 91.2% and 87.3%, respectively, for participants in the VYC-20L treatment group.3 The alignment between the ACRS live assessment and EI- and participant-rated GAIS scores may be due to the method used for GAIS scoring. To assess improvement from baseline, the EI and the participants (using a mirror) compared both frontal and profile views live at Month 6 with digital images captured at baseline. Two hyaluronic acid filler studies also reported higher responder rates (participants showing improvement) with live vs photographic assessments and suggested that photographs might be less sensitive than live assessments for measuring observable changes.12,13
Several factors may contribute to the disparity between photographic and live assessments in this study. Assessment of photographs cropped to show only the lower face is an objective and standardized approach in clinical trials of aesthetic treatments; however, this method may have impacted the EI's judgment of chin protrusion, because it is evaluated in the absence of the context of the rest of the face.1,5 Small changes in facial position, camera angle, or lighting may also have affected the EI's perception of ACRS improvements by photographic assessment.7,15 In addition, when the pogonion was injected, potential movement of the labiomental sulcus anteriorly could have caused forward protrusion, because some product may have entered the region. This could be confounding to an EI assessing chin (pogonion) protrusion by ACRS in a photographic assessment, because it may reduce the apparent pogonion projection relative to the labiomental sulcus.
To provide balance to the 3D structure of the chin for an optimal aesthetic outcome, the prejowl sulci and menton were also treated to enhance width and length of the chin in addition to projection. In total, ∼40% of initial and touch-up VYC-20L injection volume went into the pogonion, ∼20% of the volume went into each prejowl sulcus, and ∼20% of the volume went into the menton. Although the prejowl sulci and menton do not contribute to chin projection, they do contribute to overall aesthetic improvements that would not be captured on a 2D profile image or a single photonumeric scale.
Live assessments were likely more thorough than photographic assessments, because the EI could spend more time closely examining the chin from multiple angles and assess how the specific effects of treatment in the chin area affected the global aesthetics of the face. However, live assessments have the potential to introduce some biases. The EIs performing a live assessment may experience unconscious bias due to their ability to assess other variables outside of the chin such as facial symmetry, or due to personal interactions with the participant, although EIs and participants were instructed not to discuss treatment groups.10,16
Insights from the current analysis may have implications for future study designs, because the results suggest that photographic analysis may not be as sensitive a method as needed for determining accurate outcomes and that improved measurement tools are needed. Newer technology has the potential to reduce the washout that occurs with flash photography. In addition, the observed alignment of the live assessment results with the results of PRO assessments suggests that live assessments may be better suited to clinical practice goals because, while the cropped 2D images of some scales are good for capturing effectiveness based on a single parameter, live assessments capture all aspects of beauty, including harmony, balance, and global aesthetic improvement. This underscores an important difference between clinical trial results that often treat to a scale based on 2D images, compared with real-world practice that treats to improve overall facial balance and harmony. If live assessments could be performed in a more standardized manner, they could perhaps be incorporated into clinical trial scales.
In a real-world clinical practice, live assessments may not always be feasible due to patient volume and time constraints; therefore, photographic assessments are commonly performed, especially for documentation purposes. Standardizing photography conditions (eg, lighting, participant positioning), image detail, contrast, and coloring, and multiple image planes and angles may enable practitioners to achieve more consistent and complete aesthetic outcome assessments, particularly in conjunction with live assessments.15,17-22 Specific considerations regarding photographic equipment and procedures for capturing uniform, reproducible, high-quality aesthetic images were previously published and can guide clinicians in their practice.15,17-22
This analysis has some limitations. Although the study duration was 12 months, the current analysis was limited to the 6-month time point. The study population was skewed toward females and lighter skin types, potentially limiting the generalizability of the results to a broader, more diverse population, including males, who may have different aesthetic needs from the population studied here.3 In addition, the predominance of lighter skin types in this study limits its ability to further inform our understanding of the challenges associated with evaluating photographic vs live assessments in skin of color. Because the responder rate endpoint (≥1-point improvement on the ACRS score from baseline to Month 6) was calculated individually for each participant, which effectively made each participant serve as their own internal control, factors such as optional touch-up treatment, length of the washout period, and differences in injection technique (needle vs cannula) would be expected to impact the outcomes of both the live and photographic assessments similarly, thereby minimizing potential bias in the results. Finally, although comparison between standard 2D photography and 3D photography is beyond the scope of the present study, this comparative analysis may be useful to consider for future studies.
CONCLUSIONS
VYC-20L was safe and effective when injected into the chin to treat chin retrusion. More participants were rated by EIs as improved on the ACRS at Month 6 when live (3D) assessments were performed than when photographic (2D) assessments were done. These improvements were consistent regardless of baseline ACRS severity, injection volume, cannula usage, and investigation site, and have been observed across studies. These data suggest that live assessments permit a more global perspective of how changes in chin protrusion affect overall facial harmony. Live assessment helps assess overall facial improvement achieved by correction of chin retrusion.
Supplemental Material
This article contains supplemental material located online at www.aestheticsurgeryjournal.com.
Acknowledgments
Allergan Aesthetics, an AbbVie Company (Irvine, CA, USA), and the authors thank the participants, study sites, and investigators who participated in this clinical trial, including David Bank, MD; Kenneth Beer, MD; Brian Biesman, MD; Leslie Baumann, MD; Valerie Callendar, MD; Jeffrey Dover, MD; Jeanine Downie, MD; Dee Anna Glaser, MD; Mitchel Goldman, MD; Joely Kaufman-Janette, MD; William Phillip Werschler, MD; and Edwin Williams, MD.
Disclosures
Dr Dayan is a researcher, speaker, and consultant for AbbVie (North Chicago, IL). Dr Green is an advisory board member, speaker, and clinical trial investigator for Allergan Aesthetics, an AbbVie Company. Dr Schlesinger is an advisory board member, investigator, and consultant for Allergan Aesthetics, an AbbVie Company. Drs Dimitrijevic, Chawla, and Sangha are employees of Allergan Aesthetics, an AbbVie Company, and own stock in Allergan Aesthetics, an AbbVie Company.
Funding
Allergan Aesthetics, an AbbVie Company (Irvine, CA, USA), funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. Medical writing support was provided to the authors by Maria Lim, PhD, of Peloton Advantage, LLC, an OPEN Health company (Parsippany, NJ, USA).
REFERENCES
FDA executive summary: general issues panel meeting on dermal fillers US Food and Drug Administration, 2021. Accessed April 1, 2022. https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-23-2021-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee-meeting#event-materials
Author notes
Dr Dayan is the medical director of DeNova Research, Chicago, IL, USA.
Dr Green is a cosmetic dermatologist in private practice in Coral Gables, FL, USA.
Dr Schlesinger is the medical director of the Clinical Research Center of the Carolinas, Charleston, SC, USA.
Dr Dimitrijevic is the director of medical affairs, Dr Chawla is the senior director of clinical development, and Dr Sangha is the associate vice president of medical affairs, Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.
Presented in part at: American Society for Dermatologic Surgery 2021, November 19-21, 2021, virtual meeting.
