RESUMO
BACKGROUND: With a wide range of hyaluronic acid (HA) filler products available, knowledge of gel characteristics is a key part of tailoring treatments to each patient's aesthetic goals. This paper presents 2 main gel characteristics - strength/firmness and flexibility - for HA fillers produced using NASHA® and OBT™ and their clinical significance for tissue performance. METHODS: Three NASHA gels (Restylane®; Restylane Silk; Restylane Lyft) and 4 OBT gels (Restylane Refyne; Restylane Kysse; Restylane Volyme; Restylane Defyne) were studied in dynamic mode using a PP25 rheometric measuring system at 25 degrees C. Gel strength/firmness was measured using frequency sweep, with G prime evaluated at 0.1 Hz. Flexibility assessments used amplitude sweep measurements between 0.1% and 10,000% strain at 1 Hz, with xStrain being the strain value at the crossover point where G prime and G double prime have the same value. Results: Restylane, Restylane Silk, and Restylane Lyft had G primes of 701, 416, and 799 Pa, respectively. OBT G primes for Restylane Refyne, Restylane Kysse, Restylane Volyme, and Restylane Defyne were 70, 160, 171, and 271 Pa, respectively. The xStrain values were 1,442% (Restylane Refyne), 908% (Restylane Kysse), 930% (Restylane Volyme), 761% (Restylane Defyne), 7% (Restylane), 19% (Restylane Silk), and 17% (Restylane Lyft). Conclusions: OBT products had high flexibility (tolerance to deformation) and low to intermediate strength/firmness, which make them appropriate for dynamic facial areas. NASHA products showed greater strength/firmness, with the potential to create lift and projection. Altogether, NASHA and OBT HA gels covered a wide range of strength and flexibility. J Drugs Dermatol. 2024;23(1):1332-1336. doi:10.36849/JDD.7648.
Assuntos
Ácido Hialurônico , Estética , Géis , Ácido Hialurônico/química , SedaRESUMO
BACKGROUND: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion. Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety. Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported. CONCLUSIONS: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261. doi:10.36849/JDD.8145.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Queixo , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Ácido Hialurônico/efeitos adversos , Injeções , Satisfação do Paciente , Resultado do Tratamento , AdultoRESUMO
BACKGROUND: Aesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin. METHODS: A randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane® DefyneTM (HADEF), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HADEF or delayed-treatment controls, and those in the HADEF group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up). RESULTS: HADEF was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HADEF group). All subjects reported satisfaction with results at 6 months after treatment with HADEF and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile. CONCLUSIONS: These results demonstrated HADEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population. LEVEL OF EVIDENCE I: 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 .
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Técnicas Cosméticas , Preenchedores Dérmicos , População do Leste Asiático , Adulto , Humanos , Queixo , Preenchedores Dérmicos/efeitos adversos , Ácido Hialurônico , Envelhecimento da Pele , Resultado do TratamentoRESUMO
BACKGROUND: Hyaluronic acid injections are increasingly administered for correction of infraorbital hollows (IOHs). OBJECTIVES: The objective of this study was to examine the effectiveness (IOH correction) and safety of Restylane Eyelight hyaluronic acid (HAEYE) injections. METHODS: Patients with moderate/severe IOHs, assessed with the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (by needle/cannula) (Day 1 + optional Month 1 touch-up) or no-treatment control. The primary endpoint was blinded evaluator-reported Month 3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement on the Global Aesthetic Improvement Scale (GAIS), patient-reported satisfaction (FACE-Q satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 patients were randomized. Month 3 GIHS responder rate was significantly higher for HA-EYE (87.4%) vs control (17.7%; P < .001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (P = .967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) vs 14.1-16.2 (control) through Month 12. Patients reported looking younger (≥71%) and less tired (≥79%) with reduced undereye shadows (≥76%) and recovered within 3-5 hours posttreatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month 12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores 72.5-72.8). Forty patients (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSIONS: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after 1 retreatment) with needle or cannula administration. Safety outcomes were reassuring.
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Técnicas Cosméticas , Preenchedores Dérmicos , Ácido Hialurônico , Satisfação do Paciente , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Ácido Hialurônico/análogos & derivados , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Preenchedores Dérmicos/administração & dosagem , Preenchedores Dérmicos/efeitos adversos , Técnicas Cosméticas/efeitos adversos , Idoso , Estética , Adulto Jovem , Método Simples-CegoRESUMO
BACKGROUND: Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HAVOL (Restylane® Volyme) is a flexible HA filler suited to contouring and volumizing the midface. METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face. RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events. CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.
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Povo Asiático , Técnicas Cosméticas , Preenchedores Dérmicos , Face , Ácido Hialurônico , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Ácido Hialurônico/análogos & derivados , Feminino , Preenchedores Dérmicos/administração & dosagem , Preenchedores Dérmicos/efeitos adversos , Pessoa de Meia-Idade , Adulto , Técnicas Cosméticas/efeitos adversos , Masculino , Resultado do Tratamento , Estética , Satisfação do Paciente , Método Simples-Cego , ChinaRESUMO
BACKGROUND: The growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed. AIMS: The inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods. METHODS: The STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon. RESULTS: The establishment of a global database for tracking filler-related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non-medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field. CONCLUSIONS: The STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.