Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study.

BACKGROUND: Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation. OBJECTIVES: This postmarket investigation evaluated the long-term performance and safety of and patient satisfaction with Princess VOLUME PLUS Lidocaine (PVPL; now Saypha VOLUME PLUS Lidocaine) for the correction of midface volume deficit (MVD). METHODS: This was an open-label, prospective, interventional, multicenter, noncomparative, postapproval study of 91 patients with moderate or severe MVD (grade 2 or 3 on the 5-point Midface Volume Deficit Severity Scale, or MVDSS). At Day 0 (Visit 1), patients were treated with PVPL; they returned for follow-up assessments at weeks 2, 4, 12, 24, 36, and 52 and had long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed with the MVDSS, Global Aesthetic Improvement Scale (GAIS), and a subject satisfaction scale. Adverse events were collected to assess safety throughout the study. RESULTS: Four weeks after treatment, 100% of injected patients improved by ≥1 grade on the MVDSS compared to baseline, with improvements still visible in 77% of patients 52 weeks after treatment. Based on the GAIS and post hoc survival analysis, the treatment effect was maintained for a median of 386 days, and in severe cases the effect lasted longer, which seemed to be independent of the volume injected at baseline. No serious side effects were reported. Results were substantiated by high patient satisfaction. CONCLUSIONS: Princess VOLUME PLUS Lidocaine was perceived as safe and effective by patients and investigators, with long-term aesthetic improvement in moderate and severe cases.

A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds.

The aim of this study was to investigate the safety and performance of Princess VOLUME Lidocaine in nasolabial fold correction. In this prospective, open label, multicenter, postmarket study subjects received injections of Princess VOLUME Lidocaine into both NLF at Baseline (Day 0) and if considered necessary by the investigator, at Week 2 (touch-up treatment). This study was conducted in Austria at the Department of Dermatology and Venereology, Medical University of Graz, at the medical aesthetic center MÄZ WIEN, and at the medical aesthetic center Ordination Dr. Bartsch, Vienna. The 62 mainly female (95.2%) subjects had a median age of 52 years with two fully visible, approximately symmetrical NLFs, each scoring grade 2 or 3 on the nasolabial fold severity rating scale (NLF-SRS) developed by Croma-Pharma. The nasolabial fold severity was assessed by NLF-SRS and Global Aesthetic Improvement Scale (GAIS) 4, 24, and 36 weeks later. Adverse events (AEs) were recorded throughout the investigation. With 95.1% of subjects showing an improvement of at least 1 grade of the NLF-SRS at 24 weeks after the treatment, the primary endpoint was achieved, and clinical performance was demonstrated. Princess VOLUME Lidocaine was well tolerated, with only mild AEs, mainly injection site reactions, reported. Subject satisfaction (≥93.5%) and GAIS scores (≥93.5% improvement) were high. Princess VOLUME Lidocaine was effective in reducing NLFs as shown by an improvement in the severity of NLFs by at least one grade in 95.1% of subjects at Weeks 4 and 24.

Long-term effectiveness of a hyaluronic acid soft tissue filler in patients with facial lipoatrophy, morphological asymmetry, or debilitating scars.

BACKGROUND: Soft tissue fillers are typically used for rejuvenating an aging face; they are also employed in the treatment of certain pathologic conditions, including facial lipoatrophy, morphological asymmetry, and debilitating scars. AIMS: The aim of this clinical study was to evaluate the effectiveness and safety of Princess® Volume (PV) in patients with facial lipoatrophy (FLA), morphological asymmetry (MA), or debilitating scars (DS). PATIENTS/METHODS: This prospective, noncomparative, multicenter clinical study consisted of five visits spread across 36 weeks. Up to 60 adult patients suffering from moderate facial lipoatrophy, facial morphological asymmetry, or debilitating scars on the face were to be included. All patients were treated with an HA filler (PV). RESULTS: At Week 4, the treatment success rate in the SP was 98% (95% CI [90.4%, 100%]), as assessed by both the investigators and the patients. According to the independent reviewer, the success rate was 93% (95% CI [82.7%, 98.0%]). At Week 24, the effect was maintained in most patients, with success rates of 80% as evaluated by the investigator and 79% by the patient (95% CI [67.6%, 89.8%] and [65.6%, 88.4%], respectively). At Week 36, success rates dropped to 61% as assessed by the investigator and 59% by the patient (95% CI [46.8%, 73.5%] and [45.0%, 71.9%], respectively). CONCLUSIONS: The clinical study has proven that Princess® Volume is a safe and effective therapeutic solution for the correction of soft tissue defects in FLA and facial MA, but limited success rate to DS.

Safety And Efficacy Of Princess® FILLER Lidocaine In The Correction Of Nasolabial Folds.

PURPOSE: Nasolabial folds (NLFs) are one of the most noticeable signs of facial aging. NLFs negatively affect self-confidence and social acceptance often leading to a person's desire to improve their appearance using dermal fillers. The hyaluronic acid injectable gel implant Princess® FILLER Lidocaine (PFL) is a minimally invasive easy to administer the product. In this investigation, we assessed the safety and efficacy of PFL to correct moderate to severe NLFs over a 36-week period. METHODS: Adult women and men with moderate to severe NLFs received one injection of PFL to both NLFs. After 2 weeks, a touch-up treatment could be performed, if deemed necessary by the investigator. The change in NLF severity was assessed using the Nasolabial Fold Severity Rating Scale (NFL-SRS) developed by Croma-Pharma and the Global Aesthetic Improvement Scale (GAIS). RESULTS: Out of 60 analyzed subjects, 59 (98.3%) had improved their NLF severity by at least 1 grade on the NFL-SRS at week 4, 58 subjects (96.7%) at weeks 24 and 36. All subjects showed aesthetic improvement (GAIS), at weeks 4 and 24. The investigator judged the aesthetics as very much improved (score of 1) in 45 (75.0%) at week 4, 48 (80.0%) at week 24, and in 39 of 60 subjects, respectively (65.0%) at week 36. Thirty-six weeks post-initial treatment, 56 of 60 subjects (93.3%) were very satisfied or satisfied with the treatment. Adverse device effects (ADEs) were mild or moderate and resolved at latest 25 days post-onset. The most commonly reported ADEs were injection site hematoma and injection site pain. CONCLUSION: PFL was safe and effective in reducing the severity of NLFs. Most subjects were (very) satisfied with the treatment outcome throughout a 36 weeks investigation period.

Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess® FILLER.

PURPOSE: The aim of this study was to evaluate the effectiveness and safety of hyaluronic acid (HA) dermal filler when used in the face for medical reconstructive purposes. PATIENTS AND METHODS: Adult patients with moderately severe facial lipoatrophy (FLA), morphological asymmetry (MA) of the face, or debilitating scars (DS) on the face were included in a prospective, noncomparative, multicenter, postmarket clinical follow-up study. All patients were treated with an HA filler (Princess® FILLER), which was injected intradermally on study Day 1, with optional touch-up 2 weeks later. The effectiveness of the treatment was evaluated at Weeks 4 and 24, using a six-grade scale ranging from "excellent" to "worsening". The assessments were conducted by both the investigator and the patient and, at Week 4, by the independent photography reviewer as well. Adverse events were collected at each visit. RESULTS: Fifty-three patients were included in the study (FLA 23, MA 17, and DS 13), and 46 patients completed a 6-month follow-up (FLA 20, MA 15, and DS 11). At Week 4 (primary endpoint), the overall treatment success rate was 100% (FLA), 100% (MA), and 94% (DS), based on assessments made by the investigator, patients, and the independent reviewer, respectively. In most patients (~95%), the effect was sustained over 6 months. Treatment-related adverse events were reported in five patients (9%) and included injection site hematoma, injection site pain, and headache. CONCLUSION: Dermal filling with HA gel is a viable treatment option for the correction of various deformities of the face resulting from FLA, MA, or DS.

Liposuction - a surgical procedure in dermatology.

Liposuction is an integral part of the wide range of surgical procedures in dermatology. Dermatologists established tumescent local anesthesia in combination with the use of micro-cannulas; especially dermatologists from Germany and Austria actively designed and developed these new techniques. In this position paper, we discuss the history, various interdisciplinary aspects, the significance, and the treatment indications for this procedure as well as its role within dermatologic training programs and research. For quality reasons, members of the Germany Society of Dermatologic Surgery and the Austrian Society of Dermatologic Surgery discuss several fundamental professional aspects as well as the historical development of liposuction.

Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines.

BACKGROUND: Use of botulinum toxin for esthetic purposes has rapidly expanded over the last 20 years. IncobotulinumtoxinA, also known as NT 201, is a new botulinum toxin type A (150 kDa) that is free from complexing proteins. OBJECTIVES: A prospective, multicenter, randomized, rater- and patient-blind, international Phase III trial to investigate the noninferiority of incobotulinumtoxinA to another botulinum toxin type A, onabotulinumtoxinA, in the treatment of glabellar frown lines. METHODS: A total of 381 patients were randomized in a 3:1 (incobotulinumtoxinA:onabotulinumtoxinA) ratio to receive 24 U incobotulinumtoxinA of or onabotulinumtoxinA. Efficacy end points included the percentage of responders (patients with an improvement of ≥1 point on a 4-point facial wrinkle scale) at maximum frown at weeks 4 and 12 as assessed by the investigators, and a panel of independent raters based on standardized digital photographs. RESULTS: Four weeks after injection, response rates at maximum frown were 96.4% in the incobotulinumtoxinA group and 95.7% in the onabotulinumtoxinA group as assessed by independent raters. Analysis of the data confirmed the noninferiority of incobotulinumtoxinA. Response rates at rest were lower for both products. The rate of adverse events was low. CONCLUSION: IncobotulinumtoxinA is equally as effective as onabotulinumtoxinA in the treatment of glabellar frown lines. Both preparations were well tolerated.

Repeated botulinum toxin A injections for the treatment of lines in the upper face: a retrospective study of 4,103 treatments in 945 patients.

BACKGROUND: Although botulinum toxin type A (BoNT-A) is a common aesthetic intervention, there are few published data on treatment over more than two cycles. OBJECTIVE: To evaluate the effectiveness/safety of repeated doses of BoNT-A (Dysport, Ipsen Ltd., Slough, UK) in the upper face for reduction of wrinkles. METHODS: Retrospective, cross-sectional patient chart review from 945 patients who had received a minimum of three consecutive, documented treatment cycles. RESULTS: The glabella was treated most frequently (93.9%), with the majority (81.5%) of patients receiving treatment in more than one area of the face. BoNT-A treatments were combined with other aesthetic procedures in 57.5% of cases, mostly with fillers (37.1%). There was no evidence of tachyphylaxia: the dose applied, the interval between treatments, and satisfaction with the results remained stable over the course of treatment. Adverse events were those expected with BoNT-A treatment (most common: local bruising and ptosis) and were all mild or moderate in intensity. There was no sign of any cumulative adverse effects: indeed, the adverse-event rate decreased in later treatment cycles. CONCLUSIONS: Long-term, repeated injections of BoNT-A for corrections of wrinkles in the upper face yield a continuously high level of safety and effectiveness in actual practice.