For subjects who received VYC-15L treatment of the perioral lines, 65.4% and 66.2% were POLSS responders at Month 3 and Year 1, respectively (Table 3). Mean POLSS scores were significantly improved from 2.5 at baseline to 1.6 at Month 3 (mean change from baseline: −0.9; p < .001) and 1.8 at Year 1 (mean change from baseline: −0.7; p < .001). POLM responder rates were 50.6% at Month 3 and 30.9% at Year 1 (Table 3). For subjects who received treatment of the oral commissures with VYC-15L, 59.2% and 53.3% were OCSS responders at Month 3 and Year 1, respectively (Table 3).
Mean FACE-Q Satisfaction With Lips scores were significantly improved from baseline at each time point through Year 1 (p ≤ .001 for subjects treated with VYC-15L; Figure 3A). Similar results were obtained on the FACE-Q Satisfaction With Lip Lines module (Figure 3B). The percentages of subjects with improvement in FACE-Q Satisfaction With Lips scores and Satisfaction With Lip Lines scores at Month 3 were 96.1% (147/153) and 88.2% (135/153), respectively, and remained high at Year 1 (79.7% [98/123] and 74.8% [92/123], respectively).
On the GAIS, EIs rated 92.9% of subjects in the VYC-15L group as “improved” or “much improved” in appearance at Month 3; at Year 1, 58.5% of subjects in the VYC-15L group were GAIS responders (Figure 4).
Scores of 7 to 10 (“very satisfied”) were given for natural look of the lips by 84.4% of VYC-15L subjects at Month 3 and by 93.5% at Year 1. Similarly, scores of 7 to 10 for natural feel of the lips were given by 87.7% of subjects at Month 3 and by 92.7% at Year 1. Overall, 54.5% of subjects in the VYC-15L group showed improvement from baseline in lip hydration at Month 3.
Subgroup analysis of the primary effectiveness end point was performed by Fitzpatrick skin type groupings. At Month 3, the mean (SD) change from baseline in overall LFS score with VYC-15L was 1.1 (0.9), 1.1 (0.7), and 0.8 (0.4) for subjects with Fitzpatrick skin Types I/II, III/IV, and V/VI, respectively.
The mean scores for subject-rated procedural pain on initial treatment were 3.1 and 3.2 for VYC-15L and NASHA, respectively, and 3.1 and 3.8, respectively, on touch-up treatment, demonstrating minimal subject injection pain.
Nearly all subjects reported ISRs after the combined initial and touch-up treatments with VYC-15L and NASHA (98.1% and 98.0%, respectively); the most common ISRs were swelling (94.8% and 98.0%), firmness (91.6% and 94.1%), and lumps/bumps (91.6% and 90.2%). Rates were ≥5 percentage points lower with VYC-15L than with NASHA for redness, pain after injection, itching, and discoloration. Severe ISRs were reported less frequently in the VYC-15L group compared with the NASHA group (46.1% and 56.0%, respectively). Overall, 52.0% of subjects in the VYC-15L group and 54.0% in the NASHA group had resolution of their ISRs within 2 weeks of treatment. The most common ISRs lasting for 15 to 30 days in these respective groups were lumps and bumps (39.4% and 41.3%) and firmness (21.1% and 25.0%).
Injection site responses that were ongoing after 30 days were classified as AEs. During the initial and touch-up treatment periods, 50.0% (84/168) of subjects in the VYC-15L group and 51.8% (29/56) in the NASHA group had treatment-related AEs. The most common treatment-related AEs in the VYC-15L and NASHA groups were typical reactions to dermal fillers including injection site mass (diary term lumps/bumps, 32.1% and 26.8%, respectively), injection site bruising (17.9% and 19.6%), and injection site pain (11.9% and 21.4%). For both products, most treatment-related AEs were mild or moderate in severity; severe AEs were reported in 1.2% of subjects in the VYC-15L group and 7.1% of subjects in the NASHA group.
The time to onset of treatment-related AEs was most commonly within 1 day of treatment. Treatment-related AEs with onset after 30 days in the VYC-15L group were experienced by 4 subjects (2.4%) with lumps/bumps, 2 subjects (1.2%) with swelling, and 1 subject (0.6%) with swelling and lumps. All these AEs were of mild or moderate severity and resolved without sequelae in a mean of 96 days (range, 5–279). All but 2 of these AEs resolved without intervention: 1 case of mild lower lip swelling due to subject biting her lip was treated with acetaminophen, and 1 case of moderate lip swelling (without redness or infection) during a beach vacation was treated with doxycycline. All the lumps/bumps were reported by investigators as an accumulation of product and were not inflammatory, hot, or red. The final case was a subject with moderate upper lip swelling and a few small bumps (but no itching or redness) that improved substantially within 1 day and was completely resolved within 5 days despite the subject declining any treatment. There were no treatment-related serious AEs or deaths.
At Day 3 after initial treatment, the mean scores on the FACE-Q Recovery Early Life Impact module differed significantly between treatment groups based on nonoverlapping CIs, favoring VYC-15L (mean score: 81.1; 95% CI: 78.3–83.9) over NASHA (mean score: 73.1; 95% CI: 68.7–77.4) as less disruptive to daily activities.
Neither treatment reduced lip sensation on the 2-point discrimination and light touch assessments or affected pronunciation. A Tyndall effect was noted on Day 14 after initial treatment in 2 subjects (1.2%) who received VYC-15L and 1 subject (1.8%) who received NASHA. On the EI assessment of the features of the lips and mouth, most subjects in both treatment groups were given scores of 0 to 3 at all time points, indicating favorable EI assessments of the lips and mouth. Specific assessments included lip surface appearance (i.e., flaky, chapped, and peeling); hyperpigmentation or hypopigmentation; visible lumps and bumps; palpable lumps, bumps, or mucoceles; and firmness or nodularity. Finally, there were no differences between treatment groups for incidence of ISRs and device-related AEs when analyzed by Fitzpatrick skin type categories I/II, III/IV, and V/VI.
This study met its primary end point, with improvement in overall lip fullness similar for VYC-15L compared with NASHA at 3 months. In addition, VYC-15L treatment resulted in improvements in perioral lines at rest and subject-rated satisfaction with lips and lip lines. Further support for the effectiveness of VYC-15L was demonstrated by improvements in the appearance of perioral lines at maximal contraction, severity of the oral commissures, and in overall aesthetic appearance. The subgroup analyses showed that VYC-15L is effective for all Fitzpatrick skin types. Taken together, these findings illustrate the effectiveness of VYC-15L for lip and perioral enhancement.
Responder rates with VYC-15L treatment differed across the scales used. Specifically, responder rates for perioral line severity and oral commissures severity were generally lower than responder rates for lip fullness. Several factors may contribute to this difference. First, although responder rates were defined by ≥1-point improvements for all scales, differences in the number of reportable severity scores (i.e., 5-point LFS vs 4-point POLM and OCSS) may have affected investigator assessments. Second, the lower rates on the POLM may be related to the fact that dermal fillers are intended for treatment of static lines more so than dynamic lines. Therefore, effects of dermal fillers as measured by the POLM scale may be less pronounced. Finally, this study enrolled subjects based on lip fullness criteria, and therefore the LFS was the scale most likely to show response to treatment.
Most subjects reported improvements over baseline on the FACE-Q Satisfaction With Lips and Lip Lines modules with VYC-15L, coinciding with similar improvements on investigator-assessed global aesthetic improvement. In a study conducted in Europe, the percentage of investigators who reported they were satisfied with subject's lips and mouth was 90.2% at Month 3 and 62.1% at 1 year in subjects treated with VYC-15L.3,9 The TIs in this study and the European study favored VYC-15L over NASHA in terms of ease of injection and moldability.3,9 This observation is consistent with the product characteristics of VYC-15L, which were designed to require a low extrusion force during injection and enable ease of molding.1
Safety outcomes, including ISRs and treatment-related AEs, were consistent with previous studies with VYC-15L and other products in the Juvéderm family.1,3,4,9,10 Most treatment-related AEs occurred within 1 day of treatment. Subjects in this study were less likely to report severe ISRs after VYC-15L versus NASHA, which was also observed in subjects in the European study.3,9 Notably, mean scores on the FACE-Q Recovery Early Life Impact module on Day 3 were significantly higher in the VYC-15L group compared with the NASHA group, demonstrating that treatment with VYC-15L produces less disruption to normal daily activities compared with NASHA treatment. This confirms previous findings from the European study.3,9
In conclusion, this study shows that VYC-15L is safe and effective for lip and perioral enhancement, with treatment effects persisting through 1 year. Subjects expressed high levels of satisfaction with the treatment results, and EIs provided consistent assessments of the aesthetic improvements across multiple rating scales.
The authors thank Susan C. Taylor, MD, for her review and feedback of the manuscript outline. Treating and evaluating investigators, respectively, at each study site were D. E. Bank, MD and William Nolan, MD, Mt Kisco, NY; Ashish Bhatia, MD and Te Shao Hsu, MD, Naperville, IL; Brian Biesman, MD and Jennifer Martin, MD, Nashville, TN; Lisa Donofrio, MD and Ronald Savin, MD, New Haven, CT; R. G. Geronemus, MD and Jeremy Brauer, MD, New York, NY; Dee Anna Glaser, MD, Natalie Semchyshyn, MD and Ian Maher, MD, St. Louis, MO; Richard Glogau, MD, Patricia Engasser, MD, and Kristin Hudacek, MD, San Francisco, CA; Mary Lupo, MD and Katherine Holcomb, MD, New Orleans, LA; Alexander Rivkin, MD and Robert Cohen, MD, Los Angeles, CA; A. Shamban, MD and Soheil Simzar, MD, Santa Monica, CA; Susan C. Taylor, MD, Philadelphia, PA and Allison Britt-Kimmins, MD, Chadds Ford, PA; Susan Weinkle, MD and John Demetree, MD, Bradenton, FL; and Robert Weiss, MD and Margaret Weiss, MD, Hunt Valley, MD.
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© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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