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Background Full-face aesthetic treatment involving several treatment modalities may improve facial aesthetic outcome. Objective To evaluate clinical outcomes and patient perceptions of monotherapy with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by full-face combination treatments of ABO, HA filler, and skin-boosting HA (RSB). Materials and methods Subjects aged 35 to 50 years were randomized to monotherapy with 50 s.U ABO in the glabella or ≤1 mL HA filler in the nasolabial folds (NLFs)/cheeks. At Month 6 and Month 12, all subjects received combination treatment with ≤50 s.U ABO in the glabella, ≤2 mL HA filler in the NLFs/cheeks (and other facial areas as applicable), and ≤1 mL RSB (additional RSB treatment at Month 7). Assessments included global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events. Results Repeated full-face combination treatment with ABO, HA filler, and RSB was associated with considerably higher levels of aesthetic improvement and subject satisfaction than monotherapy with ABO or HA filler. Improvement rate of glabellar lines was increasing with each treatment. Conclusion Repeated combination treatment achieved greater change in global facial aesthetic appearance than monotherapy. Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated.

Background The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. Objectives The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance. Methods This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up. Results Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: “how rested your face looks” (P < 0.0001-0.0415), “I feel okay about myself” (P = 0.0011-0.0399), and “I feel attractive” (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were −1.4 (0.3; ASI) and −0.3 (0.4; placebo). Investigators’ live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = −0.41 and r = −0.36 [both P < 0.0001], respectively). Conclusions Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice. Level of Evidence: 1

Background Safety and efficacy of botulinum toxin A for glabellar line (GL) treatment are well established. Currently approved formulations require reconstitution before injection. Objectives The authors sought to assess 6-month efficacy, safety, and patient satisfaction of new ready-to-use abobotulinumtoxinA solution for injection (ASI) in patients with moderate-to-severe GL at maximum frown. Methods The authors conducted a phase 3, double-blind, randomized, placebo-controlled trial (NCT02353871). Patients (N = 185) were randomized (2:1) to receive ASI 50 U or placebo. GL severity was evaluated at days 8, 15, 29, 57, 85, 113, 148, and 183 employing a 4-point scale for investigator’s live assessment (ILA) and subject's self-assessment (SSA). Primary endpoint was ILA of GL at maximum frown at day 29, and secondary endpoints were ILA and SSA of GL at maximum frown (all time points), patient satisfaction with GL appearance, time to onset, and duration of action. Results Responder rates were significantly higher for ASI vs placebo (88.3% vs 1.4%; P < 0.0001) at day 29 by ILA and all time points by ILA (P < 0.0001-0.0441) and SSA (P < 0.0001-0.0036). Sixty percent of patients reported onset of treatment response on or before day 3 (P < 0.0001 vs placebo), and in 5% of patients, efficacy by ILA lasted 6 months (day 183; P = 0.0441 vs placebo). Patient satisfaction rates were significantly higher for ASI vs placebo at all visits (P < 0.0001). Safety was comparable with the known abobotulinumtoxinA profile. Conclusions ASI was significantly efficacious for improving moderate or severe GL vs placebo by investigator and patient assessment. ASI was associated with high patient satisfaction, a long duration of action, and comparable safety profile to abobotulinumtoxinA. Level of Evidence: 1

Background Age-related changes affecting facial areas can be corrected using minimally invasive dermal fillers. The use of polycaprolactone-dermal filler (PCL-filler) in aesthetics is increasing. Objective To evaluate the long-term safety and efficacy of the PCL-filler, in a European, multicenter, prospective study. Materials and methods Subjects (n = 90) with moderate/severe nasolabial folds (Wrinkle Severity Rating Scale [WSRS]: 3 to 4) were treated on Day 0 with a single injection of similar volume on each side; safety and efficacy assessments were performed over an 18-month period. In 1 of the 3 study centers, safety was evaluated at 30 months. Results At Month 12 (M12; primary endpoint), 84% of subjects showed a ≥1-point improvement on the WSRS (M6: 92%; M18: 64%). From the investigator/subject's evaluation, from Day 7 to M12, Global Aesthetic Improvement was reported for >90% of subjects, with the effect maintained for up to 18 months in >80% of patients. Subjects/investigators reported high satisfaction and skin quality improvement. Most of the immediate injection-site reactions disappeared after 2 to 4 days. No severe or unexpected adverse events were reported. Conclusion This study demonstrated the long-term safety and efficacy of the PCL-filler, with safety confirmed for up to 30 months.

The beneficial role of subcutaneous adipose tissue in skin rejuvenation derived from its capacity to fill the under‐layer volumes but also from its ability to regulate the extracellular matrix production by dermis fibroblasts. Hyaluronic acid (HA), a major component of the extracellular matrix, is a commonly used injectable dermal filler showing excellent efficiencies to maintain tissue augmentation even after its biodegradation. To improve their stability, the HA molecules can also be “cross‐linked” to each other. The effects of cross‐linked HA‐based fillers on the dermal structure are well known. For safety reasons, most of the physicians prefer to use the blunt cannula for injections. However, evidences showed that the cannula could not be located in the dermis, but it passes through immediate hypodermis and the long‐lasting effect of cross‐linked HA‐based fillers may be related to its effects on adipose tissue. To test whether cross‐linked HA has a direct effect on human adipocytes, we treated isolated adipocytes and precursors cells from human skin donors with cross‐linked HA. Biochemical and cellular analysis demonstrated that treatment by cross‐linked HA showed beneficial effects on differentiated cell adherence and survival as well as reduced basal and induced lipolysis in fully mature adipocytes. Taken together, these data showed that cross‐linked HA promoted cell adherence and preserved the adipogenic capacity of preadipocytes during prolonged cell culture, bringing additional evidences of the beneficial role of cross‐linked HA‐based fillers in maintenance of the subcutaneous fat mass. This first study could defend a preventive approach to facial volume loss during natural aging.

BACKGROUND In clinical practice, different upper facial areas are commonly treated together. OBJECTIVE To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period. MATERIALS AND METHODS In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of "none" or "mild" or a ≥1-point improvement in MAS scores. RESULTS A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection. CONCLUSION IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).

ANESTHESIA AND INSTALLATION The procedure is carried out under general anesthesia in order to avoid heavy inltrations that modify reliefs. The intubation probe should be xed using interdental thread in order for the cheeks to remain free and for the head to rotate. The inltration (adrenalized Xylocaine) is limited to the areas concerned by the cutaneous incision and the strict subcutaneous detachment carried out at the beginning of the procedure (Figure 66.1).

Full-face rejuvenation with dermal fillers in patients with multiple aesthetic indications is rarely studied.To assess whether a new range of hyaluronic acid filler is suitable for full-face rejuvenation and to evaluate efficacy, safety, and patient satisfaction.In this 6-month study, participants could receive five different fillers from the same range (HA(E) )for up to eight indications (periorbital lines, tear troughs, cheeks, cheek folds, nasolabial folds, upper lip lines, lips, and marionette lines). Outcomes included global aesthetic improvement, improvement in each indication, adverse events, local tolerability, and satisfaction.Seventy-seven participants with a mean age of 54.5 were enrolled; 48.1% had five or more indications treated. Mean total injection volume (baseline and touch-up) per participant was 6.7 mL. At month 6, 92.1% of participants remained at least improved over baseline, 79.7% of participants were satisfied or very satisfied with the durability of the results, and 63.0% of participants felt a lot or much better than before injection. No specific safety concerns were reported except expected injection site reactions.In participants with multiple indications, full-face rejuvenation using HA(E) provided effective, safe, satisfactory results.

Summary Background Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft tissue defects. Aim To compare the efficacy and safety of a novel HA filler, HAE (Emervel Deep), with those of HAP (Restylane Perlane) in the treatment of severe nasolabial folds (NLF). Patients/Methods A split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive injection of HAE or HAP on their left or right NLF. Efficacy was evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Local tolerability was assessed based on subject diary during the first 3 weeks after injection. Adverse events were also evaluated. Results At both weeks 12 and 24, the mean improvement in WSRS from baseline was significantly greater for HAE than for HAP (1.58 ± 0.89 vs. 1.33 ± 0.82 at week 24; P = 0.002). Similar volume of both products was injected at baseline and touch-up. Both fillers were well tolerated, with similar worst score distribution and mean score for erythema, edema/swelling, bruising, and pruritus. Significantly less severe pain/tenderness was reported with HAE than with HAP (P

Botulinum toxin A (BTX-A) is used to treat glabellar lines but the rigorous demonstration of its efficacy in a well-designed study had never been reported.This study was designed to evaluate the efficacy and the safety of 3 doses of BTX-A in the treatment of glabellar lines.A total of 119 patients with moderate to severe glabellar lines at rest were treated with 25, 50, or 75 U of BTX-A (Dysport, Ipsen) or placebo divided into 5 intramuscular glabellar sites. Outcome measures included evaluations of glabellar lines by independent experts from blinded standardized photographs at rest 1 month after treatment, physician evaluations, and patient assessments during a 6-month period.A significant efficacy was reported for the 3 BTX-A groups for at least 3 months after injection (at least P.015). Investigator and patient evaluations suggested that 50 U was the optimal dose. BTX-A was well tolerated. No blepharoptosis was reported. An evaluation in blinded conditions by independent experts was necessary because the results were overestimated by the investigators.BTX-A is an effective and safe treatment for glabellar lines.

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.