Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport®/Azzalure®): Primary Results of the APPEAL Noninterventional Study.

BACKGROUND: Although the short- and long-term effectiveness of abobotulinumtoxinA (Dysport®/Azzalure®) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting. METHODS: APPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 abobotulinumtoxinA injection cycles for moderate-to-severe GL, according to routine clinical practice. Subjects completed a satisfaction questionnaire at 3 weeks (± 7 days) after each cycle. Primary endpoint included subjects' overall satisfaction with GL after three injection cycles. Secondary endpoints included satisfaction after Cycles 1 and 2 and factors associated with satisfaction after each cycle. Physician satisfaction was also assessed after Cycles 1 and 3. RESULTS: Of 150 subjects enrolled, 135 completed the overall subject satisfaction questionnaire after Cycle 3. At 3 weeks after Cycle 3, 99.3% of subjects were 'very satisfied' (74.1%) or 'satisfied' (25.2%) with GL. Levels of subject satisfaction and associated factors after Cycles 1 and 2 were as large and significant as after Cycle 3 (83-100%, depending on question). Physicians' satisfaction with GL appearance, facial expression, and overall satisfaction was almost complete after the first injection (≥ 97.4%) and unanimous after the third (100%). CONCLUSIONS: In the APPEAL study, overall satisfaction was high after three abobotulinumtoxinA injection cycles for GL based on both subjects' (99.3%) and physicians' (100.0%) assessments. High levels of subject satisfaction reported after Cycle 1 were maintained with repeated injections. No new safety signals were observed. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Trial registration NCT02353897.

Novel administration technique for large-particle stabilized hyaluronic acid-based gel of nonanimal origin in facial tissue augmentation.

The use of large-particle stabilized hyaluronic acid-based gel of nonanimal origin (NASHA™) for facial aesthetic procedures is widespread and increasing. A panel of experts with extensive clinical experience with NASHA based gel recently attended an advisory board meeting to develop guidelines for its use in volumetric tissue augmentation.Discussions included details of the blunt-cannula injection technique currently recommended for administration of large-particle NASHA-based gel. With the aim of optimizing patient comfort and control over administration of NASHA-based gel, the panel members explored an alternative,sharp-needle technique. In this article we describe the new technique in detail, together with practical recommendations and precautions. The technique has several advantages over blunt-cannula injection: improved patient comfort, lack of need for a skin incision, increased precision regarding the implant position, and improved control of injection volume. However, the sharp-needle technique requires a high level of skill and a good knowledge of facial anatomy.

Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study.

BACKGROUND: Hyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects. METHODS: Subjects received treatment with Juvéderm(™) Voluma(™) to the malar area, based on the investigators' determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS). RESULTS: Of the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma(™) at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma(™), with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported. CONCLUSION: Voluma(™) is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.