High Patient Satisfaction of a Hyaluronic Acid Filler Producing Enduring Full-Facial Volume Restoration: An 18-Month Open Multicenter Study.

BACKGROUND: Volume restoration is an essential part of facial rejuvenation. OBJECTIVE: To assess long-term full-facial volume restoration using HAEL Volume Lidocaine hyaluronic acid filler. METHODS: An 18-month open study in 60 subjects with at least Grade 2 on the 4-point volume loss scale (VLS) for full face and at least 2 indications affected among chin, temporal areas, jawline, cheeks, cheekbones, and nasolabial folds (NLF). Performance was assessed by VLS, Lemperle rating scale (LRS), investigator Global Aesthetic Improvement Scale (GAIS), and 3-dimensional (3D) imaging. RESULTS: Most subjects (71.6%) had 3 or 4 indications injected, most commonly cheekbones (96.7%) and NLF (93.3%). At 18 months, at least a 1-grade improvement in VLS was observed for full face (68.3% of subjects), chin (77.8%), temporal areas (73.7%), cheeks (66.6%), cheekbones (58.6%), jawline (43.1%), and NLF (71.4%; LRS). For all indications, more than 60% of the volume gained at 3 weeks was sustained at 18 months based on 3D digital imaging. At 18 months, 95.0% of subjects had improved full-face GAIS and all subjects were satisfied with their aesthetic outcome. One subject (1.6%) had treatment-related adverse events. CONCLUSION: Full-facial volume restoration was well sustained over 18 months with high patient satisfaction and good tolerability.

Avaliação da segurança e eficácia de novo preenchedor à base de ácido hialurônico no tratamento dos sulcos nasolabiais e contorno dos lábios / Safety and efficacy evaluation of a new hyaluronic acid based filler in the treatment of nasolabial folds and lips outline

Introdução: o uso da técnica de preenchimento cutâneo vem crescendo nos últimos anos. O ácido hialurônico é um dos preenchedores dérmicos temporários mais usados na correção de rugas, linhas e sulcos faciais por ser seguro e eficaz. Objetivo: avaliar a eficácia e segurança do produto Perfectha®, novo preenchedor à base de ácido hialurônico, para a correção dos sulcos nasolabiais e contorno dos lábios. Métodos: estudo aberto, multicêntrico, não randomizado, não controlado, incluindo 87 mulheres saudáveis.A avaliação da eficácia foi realizada através das escalas de melhora estética global (Global Aesthetic Improvement Scale - GAIS) e da classificação de gravidade das rugas (Wrinkle Severity Rating Scale - WSRS). A segurança foi avaliada por observação e relato de eventos adversos. Resultados: uma semana após a aplicação do preenchedor, foi observada melhora nos sulcos nasolabiais de 86% das mulheres e nos lábios de 89% delas. Reação inflamatória, transitória, leve ou moderada e equimoses ocorreram em 15% e 9% das pacientes, respectivamente, sobretudo nos sulcos nasolabiais. Duas pacientes apresentaram herpes simples labial após o tratamento dos lábios. Os bons resultados se mantiveram em 76% e 57% das mulheres, nos sulcos nasolabiais e em 72% e 45% delas nos lábios, após três e seis meses, respectivamente. Conclusão: o preenchedor Perfectha® mostrou-se eficaz e seguro para essas indicações.

Introduction: The use of dermal filling techniques for soft tissue augmentation has greatly increased in recent years.Hyaluronic acid is one of the most used temporary dermal fillers in the treatment of facial wrinkles, furrows, and folds due to its effectiveness and safety. Objective: To evaluate the efficacy and safety of Perfectha®, a new hyaluronic acid filler, for nasolabial folds and lip correction. Methods: Open, multicenter study comprising 87 women. Efficacy was evaluated by the Global Aesthetic Improvement Scale and the Wrinkle Severity Rating Scale. Safety was evaluated through observation and the reporting of side effects. Results: One week after the injection of the filler, improvement in nasolabial folds and lips was observed in 86% and 89% of the women, respectively. Mild or moderate transient inflammatory reaction and ecchymoses occurred in 15% and 9% of patients, respectively, mainly in nasolabial folds. Two patients presented labial herpes simplex after treatment of the lips.The good results were maintained in 76% and 57% of women for nasolabial folds and in 72% and 45% of women for lips after 3 and 6 months, respectively. Conclusion: Perfectha® was effective and safe for these indications.