Long-Term Efficacy and Tolerability of a Medium G' HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone.

Purpose: Injectable hyaluronic acid-based fillers are commonly used for the correction of skin contour irregularities and to smooth skin depressions formed by volume loss during the aging process. These fillers are particularly efficient to restore perioral skin depressions/wrinkles or to correct topographical anomalies. The European directives require a continuous evaluation of the performance of these medical devices, particularly for CE marked products. Methods: An 18-month prospective randomized single-blind study for the efficacy and safety of ART FILLER Universal (AFU) was performed on the lips, the nasolabial folds, and the marionettes lines. The evaluations were performed on 153 subjects enrolled in this study. The efficacy, the longevity, and the safety were evaluated for the injected areas via area specific clinical scoring after a single injection with the filler and with no re-touch. Results: We showed here that filler injection induced potent improvements of volume restoration after a single injection on all the treated areas. These beneficial properties of the filler were significant 3 weeks after injection and during the whole study period. Moreover, injections of the filler were well tolerated by the subjects. The recorded adverse events are routinely seen with HA fillers for face volume corrections, and most of these local reactions resolved within 14 days. Conclusion: AFU was well tolerated and showed a continuous efficacy for at least 18 months, in exploratory analyses.

Long-term efficacy and safety of a hyaluronic acid dermal filler based on Tri-Hyal technology on restoration of midface volume.

INTRODUCTION: Art Filler Volume (AFV) is a hyaluronic acid (HA)-based filler formulated with "Tri-Hyal" technology, a unique combination of three sizes of HA chains. This study assessed AFV efficacy and safety over 18 months when used to restore midface volume. METHODS: During this open-label study, a maximum of 1.8 mL AFV was injected into each cheek area on Day 0 (D0). Subjects were evaluated at D21, when, if necessary, a retouch could be performed (maximum 1.2 mL per cheek). Subjects were evaluated at seven follow-up visits through to D540. The primary assessment was based on the evolution of the Medicis Midface Volume Scale (MMVS) grade on D21. Secondary outcomes were local and general adverse events, investigator- and subject-assessed Global Aesthetic Improvement Scale scores and changes in self-esteem. RESULTS: Of the 79 healthy Caucasians enrolled (mean age 54.8 years), 25 required a second injection. In the intention-to-treat population, mean overall MMVS scores improved significantly from D0 (3.2 ± 0.4) to D21 (1.8 ± 0.6) and D42 (1.7 ± 0.6) (all p < 0.0001). MMVS scores for each cheek also improved significantly, irrespective of retouch on D21: 22% of injections showed a persistent benefit at D540 without retouch. The most common adverse events were pain on palpation (19%), erythema (15%) and edema (13%); most were mild or moderate and resolved within 2 weeks. CONCLUSION: AFV produces a sustained objective and subjective midface volume restoration in female and male subjects, often without retouching, and was well tolerated.

Comparative clinical study for the efficacy and safety of two different hyaluronic acid-based fillers with Tri-Hyal versus Vycross technology: A long-term prospective randomized clinical trial.

BACKGROUND: Hyaluronic acid-based fillers have an immediate volumizing effect for the treatment of dermal contour deformities and to smooth dermal depressions formed by the loss of volume. A previous study on 2016-2018 has shown the efficacy and safety of the HA-based filler ART FILLER® Volume on the midface only, but not in a comparative manner. METHODS: In this context, an 18 months prospective randomized single-blind study of the non-inferiority of ART FILLER® Volume versus the reference product Juvéderm Voluma® was performed on the midface, temple, and jawline, and non-comparative study on the chin. The efficacy and the longevity were evaluated for the selected face areas via dedicated clinical scoring systems after a single filler injection without any re-touch or re-injection. The short- and long-term adverse effects were also recorded. RESULTS: The observations confirmed the non-inferiority of ART FILLER® Volume versus the reference product on the different injected areas. For both fillers, the beneficial effects on volumes restoration were maintained 18 months post-injection; however, these effects were diminished among the time. Furthermore, injections of Art Filler® Volume were well tolerated by the subjects and showed less acute side effects compared with the reference product that may be explained by a lower induction of inflammation.

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.

BACKGROUND: Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers. AIMS: To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines. MATERIALS AND METHODS: This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS). RESULTS: In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up. CONCLUSIONS: The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.

Liquid Spreader Grafts: Internal Nasal Valve Opening with Hyaluronic Acid.

BACKGROUND: Nasal valve disorders frequently give rise to nasal obstruction. Dermal fillers could be used in the internal valve area to generate valve widening. The goal of this study was to report our "liquid spreader" procedure consisting in the injection of hyaluronic acid (HA) at the internal nasal valve in patients complaining of nasal obstruction. METHODS: The procedure described in this paper is suitable for patients with unilateral or bilateral nasal obstruction related to architectural features resulting in narrowing of the internal nasal valve. HA is injected along the internal valve from a single entry point located at the anterior part of the internal valve, thus creating a volume which will induce nasal valve widening. Rhinomanometries and visual analog scales (VAS) regarding nasal obstruction were collected before and after the procedure. RESULTS: Sixteen patients were enrolled (7 females). Mean age was 44 years (min=24 y-o, max=65 y-o). Thirteen presented nasal valve narrowing without septal deviation while 3 patients had high septal deviation. Before injection, mean nasal resistances were 3.4±5.6 sPa/mL (min=0.55, max=19.8). One month after injection, mean nasal resistances were 0.38±0.26 sPa/mL (min = 0.20, max = 0.85). The difference was statistically significant (p=0.049). VAS scores were improved with a trend back to baseline after 12 months. CONCLUSIONS: The liquid spreader is a useful procedure that can be combined with non-surgical esthetic rhinoplasties. 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 .

A Safe Nonsurgical Rhinoplasty Procedure.

SUMMARY: Nonsurgical rhinoplasty procedures are not without risks: although rare, intravascular injections of hyaluronic acid can lead to serious complications. Very few authors have reported using cannulas for filler injection in the nose. The purpose of this article is to describe how the authors perform nonsurgical rhinoplasty using a single entry point and cannulas, significantly reducing vascular and infection risks. The procedure described in this article can be applied to all indications of nonsurgical rhinoplasty. The key point of the authors' procedure is the definition of a single, medial entry point. Using a 5-cm, 25-gauge, dome-shaped cannula, all nasal regions can be reached, from the anterior nasal spine to the nasion. The authors' nonsurgical rhinoplasty procedure using cannulas reduces complications and provides results similar to those achieved with needles.

A hyaluronic acid-based filler reduces lipolysis in human mature adipocytes and maintains adherence and lipid accumulation of long-term differentiated human preadipocytes.

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.

[Botulinum toxin, description and clinical applications in the treatment of the face wrinkles]. / La toxine botulique description et applications cliniques dans le traitement des rides du visage.

UNLABELLED: The botulinum toxin is used more and more in the treatment of the wrinkles of the face and mainly in its 1/3 superior part. OBJECTIVES: To describe the technique of injection and to establish a treatment program based on the anatomical data. MATERIALS AND METHODS: The description of the muscles and the elements constituting the face makes it possible to specify the play of the muscular balances of the face. RESULTS: The technique of injection needs certain requirements: It must be of small quantity and not diffuse. The treatment program must be integrated in a unit based on the study of each muscular group of the face and the opposite skin to release a reasonable attitude in the handling in safety of this toxin. CONCLUSION: The technique is sure and effective by respecting the indications and the conditions of use.

Adenoma of the middle ear: a rare and misleading lesion.

PURPOSE: To discuss features of the adenoma of the middle ear according to the literature. BACKGROUND: Adenoma of the middle ear is a rare tumor, which is developed from the tympanic cavity. Its histopathologic appearance is benign and is characterized by a glandular and neuroendocrine component. METHODS: The authors report their experience with two cases, treated surgically by tympanoplasty. RESULTS AND CONCLUSION: The treatment is exclusively surgical and must be complete to prevent recurrence.