Creation and Validation of a Photonumeric Scale for Assessment of Infraorbital Hollows.

BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers. OBJECTIVE: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice. METHODS AND MATERIALS: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreements during the TIOHS validation were excellent. The mean intrarater-weighted Kappa score between the 2 sessions of photographic validation was 0.92, while inter-rater interclass correlation coefficient (ICC) was 0.92 for the combined sessions. The average intrarater-weighted Kappa score and inter-rater ICC for the live validation reached 0.80 and 0.76, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 82% and 86% of cases, respectively. CONCLUSION: The intrarater Kappa scores and inter-rater ICCs met their predetermined acceptance criteria of >0.70. The TIOHS is a repeatable and reproducible clinician-reported outcome for health care providers to classify IOHs in clinical trials and routine patient care. A 1-grade difference on the TIOHS can detect a clinically meaningful difference in infraorbital hollowing.

Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics.

BACKGROUND: Maximizing patient comfort during hyaluronic acid gel injection is a common concern that is usually addressed by selecting fillers with lidocaine. OBJECTIVE: Two randomized, double-blinded, split-face trials aimed to demonstrate noninferiority of specific hyaluronic acid fillers incorporating mepivacaine (RHA-M) versus their lidocaine controls, at providing pain relief. METHODS: Thirty subjects per trial received injections of RHA R -M versus RHA R , and RHA4-M versus RHA4, respectively, in the perioral rhytids (PR) and nasolabial folds (NLF). Pain was assessed on a visual analog scale; aesthetic effectiveness was evaluated with validated scales, and safety was monitored based on common treatment responses (CTRs) and adverse events (AEs). RESULTS: RHA-M fillers proved as effective as their lidocaine counterparts at reducing pain (noninferior, p < .0002 and p < .0001). Bilateral wrinkle improvement was measured both in the PR (-1.5 ± 0.6 points on each side) and in the NLF (-1.8 ± 0.6 and -1.9 ± 0.5 points) trials at one month, with virtually identical responder rates (≥96.7%). Common treatment responses and AEs were similar between treated sides, and none was clinically significant. CONCLUSION: Resilient hyaluronic acid fillers with either mepivacaine or lidocaine are equally effective at reducing pain during treatment and equally performant and safe for correction of dynamic facial wrinkles and folds.

Injection Guidelines for Treating Midface Volume Deficiency With Hyaluronic Acid Fillers: The ATP Approach (Anatomy, Techniques, Products).

Midface rejuvenation is among the most valuable indications of hyaluronic acid dermal fillers, because malar projection and full upper cheeks significantly contribute to a youthful appearance. Hyaluronic acid fillers have evolved over the past 2 decades to meet specific clinical needs such as strong projection capacity and adaptability to facial dynamism. As a result, they now represent the treatment of choice for midface rejuvenation throughout age ranges by offering the potential for noninvasive treatment, immediate results, and minimal downtime. Because the 5-layered structure of the midface plays a central role in the human face, injecting the midface area may also indirectly improve other aesthetic concerns such as infraorbital hollowing and nasolabial folds. Nonetheless, midface rejuvenation requires a tailored treatment approach and a thorough knowledge of anatomy to minimize procedural risks and achieve natural-looking results. This article provides an extensive anatomical description of the midface and of the usual course and depth of vascular structures circulating nearby to delineate a treatment area and minimize procedural risks. Furthermore, considering the differential mobility and mechanical constraints of each layer of the midface, a multilayer treatment algorithm is proposed for adapting the treatment strategy to patient specificities (including age, gender, skin type, and morphology). Emphasis is also placed on desirable filler properties to create deep structural support on the one hand and accompany facial movement on the other hand.

Creation and validation of a photonumeric scale for assessment of lip fullness.

BACKGROUND: Validated, objective clinical scales are needed to assess aesthetic improvement of the lips after augmentation with dermal fillers. OBJECTIVE: To develop a lip fullness rating scale and establish its reliability for grading subjects in clinical trials or routine practice, and sensitivity for detecting clinically meaningful changes. METHODS: The Teoxane Lip Fullness Scale (TLFS), a proprietary, 5-grade photonumeric scale, was developed by clinical experts based on real subject photographs and was validated through both photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreement for the TLFS was substantial to almost perfect. Mean intra-rater weighted Kappa score between the two rounds of photographic validation was 0.92, and inter-rater agreement was substantial with an ICC of 0.93 for the combined rounds. Average intra-rater weighted Kappa score and inter-rater ICC for the live validation were equally high, reaching 0.91 and 0.89 respectively. Additionally, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference on the scale in 90% and 98% of cases, respectively. CONCLUSIONS: The intra-rater Kappa scores and inter-rater ICC met their pre-determined acceptance criteria of >0.70 in the photographic and live validation. The TLFS was shown to be a repeatable and reproducible Clinician Reported Outcome (Clin-RO) for healthcare providers to classify lip fullness both in clinical trials and in routine patient care. A 1-grade difference on the TLFS can detect a clinically meaningful difference in lip fullness.

A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up.

BACKGROUND: Monitoring the effectiveness, safety and emerging uses of hyaluronic acid (HA) fillers in their wide range of indications requires a holistic approach. PURPOSE: To propose an observational study design aiming to gather real-world evidence (RWE) and continuously evaluate the performance and safety of marketed devices in routine practice. MATERIALS AND METHODS: A prospective, observational registry was initiated at six European sites. Investigators enrolled any subject receiving at least one injection with a target study device (TEOSYAL Deep Lines [HADL] and/or Global Action [HAGA]). They followed their routine practice regarding injection technique, volume, and subject follow-up. Effectiveness was evaluated at 3 months using the global aesthetic improvement scale (GAIS). Safety was assessed based on common treatment reactions (CTR) and adverse events (AE). RESULTS: High quantity of RWE was collected following the initiation of this registry. In the first 158 subjects enrolled, 1220 injections were performed in more than 25 indications, including 679 with the target devices and 271 with devices of the same filler line. The primary objective was achieved, with 93.9% of treatments providing improvement at Month 3 according to the PI and subject. Post-injection CTR were mild to moderate and short-lived, and there was no clinically significant AE. More than 76% of treatments still provided some visible effect at month 12. CONCLUSION: Based on RWE, HADL and HAGL are effective and safe in their respective indications mostly distributed in the midface, perioral region, and lower face. Observational registries are a valuable asset in the context of post-market clinical follow-up.

Crosslinking hyaluronic acid soft-tissue fillers: current status and perspectives from an industrial point of view.

INTRODUCTION: Hyaluronan (HA)-based soft-tissue fillers are injectable crosslinked hydrogels aimed to counteract facial skin aging signs via minimally invasive procedures. The crosslinking step is required to drastically improve HA residence time in vivo and provide the gel with specific viscoelastic properties matching the clinical indications. While HA as a raw material and HA fillers are widely studied, little is reported about crosslinkers themselves used in commercial fillers. AREAS COVERED: This article introduces the specifications of the ideal crosslinker in HA fillers. The properties of commercially used crosslinkers are reviewed. An up-to-date review of innovative hydrogel fabrication alternatives is conducted, and advantages and drawbacks are discussed. EXPERT OPINION: HA fillers are predominantly manufactured using 1,4-butanediol diglycidyl ether (BDDE) which is considered as the gold standard crosslinker worldwide due to its proven and unrivaled clinical track record of more than 20 years. Extensive studies have been published covering BDDE-crosslinked HA fillers' chemistry, gel properties, and clinical effectiveness and safety. However, new hydrogel fabrication strategies have emerged, paving the way for innovative alternatives potentially bringing novel features to HA fillers. Nevertheless, major efforts must still be implemented to assess their safety, efficacy, stability and suitability for industrialization.