Improvement of Radial Cheek Lines With Hyaluronic Acid-Based Dermal Filler VYC-17.5L: Results of the BEAM Study.

BACKGROUND: Radial cheek lines (RCL) may convey an older, potentially less attractive appearance. OBJECTIVE: To evaluate the effectiveness of hyaluronic acid-based dermal filler VYC-17.5L for correcting RCL. MATERIALS AND METHODS: Fifty-three women (40-65 years) received injections of VYC-17.5L in both cheeks on Day 1 (optional Day 14 touch-up). Effectiveness was evaluated on Day 45 by subject-rated dynamic RCL improvement (Global Aesthetic Improvement Scale [GAIS]; primary end point) and independent, noninjecting investigator-rated GAIS; subject Self-Perception of Age (SPA); subject-assessed satisfaction with and natural look of treatment; and instrument-assessed changes in static and dynamic RCL roughness, amplitude, and texture (secondary end points). Safety assessments included injection site responses (ISRs). RESULTS: On Day 45, 98% of subjects rated RCL as improved or much improved (investigator rated: 95%). Subjects with same or older SPA before treatment (n = 38) perceived themselves as 2.0 and 5.5 average years younger after treatment, respectively. Day 45 mean satisfaction with and natural look of treated areas was 7.9/10 and 7.2/10, respectively. Treatment significantly improved RCL roughness, amplitude, and texture (all p < .001). Most common ISRs were hematoma (35.9%), bruising (30.2%), and irregularities/bumps (22.6%); most ISRs were mild. CONCLUSION: VYC-17.5L effectively corrected dynamic RCL, improved instrument-assessed indicators of skin quality, and resulted in younger age perception.

Improvements in satisfaction with skin after treatment of facial fine lines with VYC-12 injectable gel: Patient-reported outcomes from a prospective study.

BACKGROUND: VYC-12, a hyaluronic acid injectable gel, is designed to treat fine lines and provides improvements in other skin quality attributes. A prospective study demonstrated the safety and effectiveness of VYC-12 for the improvement of fine lines as measured by changes in skin texture. AIMS: To evaluate patient-reported outcomes in subjects treated intradermally with VYC-12 in the cheeks, forehead, and neck (optional) in the prospective study. METHODS: Subjects received an initial treatment of VYC-12 (N = 131), with a touch-up treatment, if deemed necessary, offered 30 days later, and optional repeat treatment 9 months after initial or touch-up treatment. Subjects completed the FACE-Q Satisfaction With Skin scale and assessed willingness to recommend treatment to a friend at baseline, months 1, 4, 6, and 9, and month 1 after repeat treatment. Subjects also evaluated their return to normal daily social activities. RESULTS: Satisfaction with skin improved from baseline in 90.8% of subjects at month 1, 88.4% at month 4, 83.6% at month 6, 76.4% at month 9, and 91.9% at month 1 after repeat treatment (P < .001, all time points). At least 94% of subjects returned to normal daily social activities one day after treatment (initial, touch-up, or repeat). More than 80% of subjects said they would recommend treatment to a friend at all time points through month 9 (97% at month 1 after repeat treatment). CONCLUSION: Treatment with VYC-12 significantly improved satisfaction with skin in the majority of subjects, with most subjects returning to normal activities 1 day after treatment.

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

OBJECTIVE: Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection. MATERIALS AND METHODS: In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed. RESULTS: Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate. CONCLUSION: VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.

A Prospective, Open-Label Study of Hyaluronic Acid-Based Filler With Lidocaine (VYC-15L) Treatment for the Correction of Infraorbital Skin Depressions.

BACKGROUND: Infraorbital skin depressions are one of the most troublesome facial areas for aesthetically aware patients. OBJECTIVE: Evaluate effectiveness and safety of Juvéderm Volbella with Lidocaine (VYC-15L; Allergan plc, Dublin, Ireland) for correction of bilateral infraorbital depressions. METHODS: In this 12-month, prospective, uncontrolled, open-label study, subjects aged ≥18 years with infraorbital depressions rated ≥1 on the Allergan Infra-oRbital Scale (AIRS) received injections of VYC-15L with optional touch-up treatment on Day 14. The primary efficacy measure was ≥1 AIRS grade improvement from baseline at month 1. RESULTS: Of 80 subjects initially treated with VYC-15L, 75 (94%) completed the study. All injections were intentionally deep, most using multiple microbolus technique. At 1 month, 99.3% of eyes achieved ≥1 AIRS grade improvement. The responder rate (subjects with ≥1 AIRS grade improvement in both eyes) was 99% at month 1, 92% at month 6, and 54% at month 12. Most injection site reactions (e.g., bruising, redness, irregularities/bumps) were mild and resolved by day 14. Late-onset mild to moderate edema was observed in 11% of eyes at month 6% and 4% of eyes at month 12. CONCLUSION: VYC-15L is effective and safe for the treatment of infraorbital depressions, with effectiveness lasting up to 12 months.

Creation and Validation of a Photonumeric Scale to Assess Volume Deficiency in the Infraorbital Region.

BACKGROUND: The eyes are particularly important aesthetic features of the face and revitalization of the infraorbital region has become a focus of aesthetic treatments. Published infraorbital scales to date have limitations in that they have been descriptive, subjective, or have used computer-generated images. Thus, there is an unmet need for a validated scale based on actual images. OBJECTIVE: To develop a practical photonumeric scale that respects the complex anatomy and age-related changes occurring in the orbital area. METHODS AND MATERIALS: The Allergan Infra-oRbital Scale (AIRS) was developed through a multistep process in collaboration with 16 physicians (plastic surgeons, dermatologists, and aesthetic physicians). Scale development involved both online photographs and live assessments of subjects. Interrater and intrarater reliability was assessed using intraclass correlation coefficients (ICCs). RESULTS: The final AIRS showed intrarater and interrater ICCs of 0.78 to 0.86 and 0.91 to 0.98 for live validation and 0.76 to 0.82 and 0.86 to 0.91 for online validation, respectively, demonstrating robust validity. CONCLUSION: The AIRS can be considered a photonumeric scale that accurately describes volume loss in the infraorbital region. It has been validated and is appropriate for use in research or for everyday clinical use for both live and photographic assessment.

Global 3-dimensional approach to natural rejuvenation: recommendations for perioral, nose, and ear rejuvenation.

BACKGROUND: There is a move toward a global, 3-dimensional approach to facial rejuvenation that has been prompted by advances in techniques and available products. However, little published literature exists on the procedures involved in this global approach, and currently, no validated recommendations exist. OBJECTIVES: To provide a detailed, practical guide to rejuvenation of the perioral area, nose, and ears based on expert consensus recommendations. METHODS: The aim of this approach was to take into account both volumetric and dynamic aspects of treatment, as well as the benefits of treatment combinations, for example, combining botulinum toxins with hyaluronic acid (HA) fillers and volumizers. Each set of recommendations was documented, comprising a clinical definition of the aging severity scale, together with recommendations of appropriate products, doses, site, depth, and injection techniques, as well as indication-specific rules to be respected. RESULTS: HA fillers are ideal for replenishing volume loss in the lips, while rhytides around the lips can be treated with small doses of botulinum toxin. Botulinum toxin can also be used to raise the tip of the nose, to reshape nostrils, and to narrow nasal flare, with HA fillers also be used to correct small defects. HA fillers can also be used to rejuvenate sagging, atrophic or irregular ear lobes, repair torn earlobes, or erase vertical rhytides. CONCLUSIONS: By providing practical guidance on rejuvenation of the perioral area, nose, and ears, esthetic facial physicians can achieve optimum patient outcomes.

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

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

Lower-face and neck antiaging treatment and prevention using onabotulinumtoxin A: the 2010 multidisciplinary French consensus--part 2.

BACKGROUND: Onabotulinumtoxin A has been used for many years in the aging face treatment. A survey was organized to identify current practices in France. OBJECTIVE: To develop consensual recommendations for treating aging lower face and neck with onabotulinumtoxin A. METHODS AND MATERIALS: Fifty-seven participants to six regional surveys reviewed practices and techniques for each individual treatment indication. From conference summaries and data from a questionnaire, consensual recommendations were developed. RESULTS: General considerations, key treatment rules, injection specifics (dose, site, and techniques), associated procedures/treatments, and procedure follow-up were defined by indication, i.e., nasolabial angle, nasal tip repositioning, dilated nostrils, lips and perioral area, Marionette lines and depressor anguli oris, gingival smile, risorius and zygomatic perioral muscles, masseters, chin, and platysma. For the consensus participants, current onabotulinumtoxin A use is a global preventive and corrective treatment. Overall, judicious treatment of multiple sites and adjunctive modalities, such as fillers, peels, and laser, leads to satisfactory results with a youthful, harmonious, animated, and natural-looking face. CONCLUSION: Years of experience using onabotulinumtoxin A result in sophisticated treatment approaches, more specific targeted injections, and better understanding of lower facial and neck aging, leading to satisfying therapeutic results for patients and clinicians.

How to achieve synergy between volume replacement and filling products for global facial rejuvenation.

The objective of this paper is to provide an expert consensus regarding facial rejuvenation using a combination of volume replacement (Juvéderm(®) VOLUMA(®)), filling products (Juvéderm(®) Ultra product line) and botulinum toxin. The Juvéderm product line exploits innovative 3-D technology, producing a range of cohesive, homogenous gels that produce predictable, long-lasting and natural results. The products are easy to use by practitioners and are well-tolerated by patients, and used in combination can provide additional benefits not achieved with one product alone. An assessment of facial anatomy and consideration of the aging process, as well as available treatment options, are also addressed in determining the best combination of products to use. Outcomes from a questionnaire and workshop sessions focusing on specific aspects of use of the Juvéderm product line and botulinum toxin in daily clinical practice are discussed, and recommendations for product use following debate amongst the experts are provided.

Upper- and mid-face anti-aging treatment and prevention using onabotulinumtoxin A: the 2010 multidisciplinary French consensus--part 1.

BACKGROUND: Onabotulinumtoxin A (onabotulinum) has been used for 7 years in the treatment of the aging face. A survey was conducted to identify current practices in France. OBJECTIVE: To develop consensual practice recommendations for treating the aging upper- and mid-face with onabotulinum. METHODS AND MATERIALS: Fifty-seven participants reviewed practices and techniques for each identified upper- and mid-face treatment indication. From data gathered during six regional conferences and from a questionnaire, consensual recommendations were developed. RESULTS: General considerations, key treatment rules, injection specifics (dose, site, and techniques), associated procedures/treatments, and follow-up were defined for each indication, i.e., glabellar, horizontal forehead, crow's feet and bunny lines, lower eyelid rhytides, and eyebrow repositioning and reshaping. For the consensus participants, current onabotulinum use is a global, both preventive and corrective treatment. In France, judicious lowest effective dose, treatment of multiple sites and adjunctive treatment modalities, such as fillers and peels, lead to satisfactory results for clinicians and patients with a youthful, harmonious, animated and natural looking face. CONCLUSIONS: Years of experience using onabotulinum result in sophisticated treatment approaches, more specific targeted injections, and a better understanding of facial aging, leading to satisfying therapeutic results for both patients and clinicians.

Botulinum toxin A in the treatment of glabellar lines: scheduling the next injection.

BACKGROUND: A single intramuscular treatment with botulinum toxin A (BoNT-A) into the facial muscles underlying glabellar rhytids has been shown to effectively attenuate or totally erase these lines for at least 3 months. OBJECTIVE: We sought to evaluate the optimal time for a second injection of BoNT-A (Dysport, Ipsen). METHODS: One hundred patients with moderate to severe glabellar rhytids at rest were randomized to a first, double-blind injection of 50 U of BoNT-A (n = 50) divided into 5 intramuscular sites, or placebo (n = 50). At monthly intervals between Month 3 and Month 6, the patient and the investigator consensually decided to repeat the injection with open-label BoNT-A in both groups. The main outcome was the time between the first and second injections. Responder ratings (mild or no glabellar lines) after the first and second injections, patient satisfaction, and safety were also assessed. RESULTS: At Months 3 and 4 after the first injection, the cumulative percentage of patients having a second injection was lower in the BoNT-A group compared to the placebo group, with a significant difference at Month 4. Following the first double-blind injection, responder rates were significantly higher in BoNT-A group (up to 75%) compared to placebo up to Month 4, and a large majority of patients were significantly satisfied with the BoNT-A treatment at Month 4 (75% satisfied and completely satisfied versus 9.1% with placebo) and Month 5 (86.7% versus 0%, respectively). Headache was the most frequent adverse event in the BoNT-A group (10% versus 6% in the placebo group). No blepharoptosis was reported. CONCLUSIONS: The effectiveness of 50 U of BoNT-A was confirmed for the treatment of glabellar lines. A second injection was sought within 3 to 4 months by most patients and investigators. Both injections were safe.