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

Bhojani-Lynch, Tahera; Deckers, Anne; Ohanes, Ohan; Poupard, Kevin; Maffert, Pauline

doi:10.2147/ccid.s329415

Cited by 2 publications

(5 citation statements)

References 30 publications

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“…This performance was in line with similar HA fillers currently on the market that still show visible effects 12 months after the initial application. 4 , 10-13 …”

Section: Discussionmentioning

confidence: 99%

“…As an innovative, minimally invasive alternative to surgery, fillers are now quite common for midface rejuvenation among patients and physicians, and since the 2000s hyaluronic acid (HA) fillers have truly disrupted facial rejuvenation by offering volume replacement in a safe, effective, and affordable way. 3 , 4 HA is a naturally occurring glycosaminoglycan, particularly concentrated in the soft connective tissue extracellular matrix and skin dermis. 5 Because HA alone is quickly degraded by endogenous hyaluronidase and other tissue factors (eg, oxidative and mechanical stress), most dermal filler formulations use chemically cross-linked HA to improve persistence of the implanted gel in vivo.…”

mentioning

confidence: 99%

“… 5 Because HA alone is quickly degraded by endogenous hyaluronidase and other tissue factors (eg, oxidative and mechanical stress), most dermal filler formulations use chemically cross-linked HA to improve persistence of the implanted gel in vivo. 4 Albeit chemically modified, HA fillers can be promptly degraded upon injection of high-dose hyaluronidase, which represents a key advantage of HA over other injectable materials from a safety perspective. 6 HA dermal filler injections are now routinely performed in aesthetic clinics worldwide for malar augmentation or midface contouring, yielding immediate results, minimal downtime, and a high rate of patient satisfaction.…”

mentioning

confidence: 99%

“…Because premarket clinical trials are usually designed to show effects of a filler for a given indication based on a standardized treatment protocol, once on the market and routinely utilized by healthcare practitioners, a product may end up being injected with more variable quantities and/or techniques than those evaluated by randomized controlled clinical investigations. 4 , 9 Therefore, specific postmarket study designs are needed to collect clinical evidence supporting routine practice with HA fillers. The present clinical investigation had the objective of evaluating the long-term performance of PVPL, in relation to its effectiveness and safety in the correction of moderate-to-severe midface volume deficit (MVD) in a postmarket open-label study design.…”

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confidence: 99%

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

Rzany¹,

Sulovsky²,

Sattler³

et al. 2023

Aesthetic Surgery Journal

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Background Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation. Objectives This post-market investigation evaluated Princess Volume Plus Lidocaine (now Saypha Volume Plus Lidocaine) (PVPL) long-term performance, safety and patient satisfaction for the correction of midface-volume-deficit (MVD). Methods This was an open-label, prospective, interventional, multicenter, non-comparative, post-approval study of 91 subjects with moderate or severe MVD [grade 2 or 3 on the five-point Midface Volume Deficit Severity Scale (MVDSS)]. At Day 0 (Visit 1), subjects were treated with PVPL; and, returned for follow-up assessments at week 2, 4, 12, 24, 36, 52; and long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed using MVDSS, Global Aesthetic Improvement Scale (GAIS), and Subject Satisfaction Scale. Adverse events (AEs) were collected to assess safety throughout the study. Results 4-weeks after treatment, 100%-injected subjects improved by ≥1 grade on MVDSS compared to baseline, with improvements still visible in 77% of subjects 52-weeks after treatment. Based on 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 subjects/investigators, with a long-term aesthetic improvement in moderate and severe cases.

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“…This performance was in line with similar HA fillers currently on the market that still show visible effects 12 months after the initial application. 4 , 10-13 …”

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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

Rzany¹,

Sulovsky²,

Sattler³

et al. 2023

Aesthetic Surgery Journal

View full text Add to dashboard Cite

show abstract

“…In terms of safety, the products were of course tested via a library of biocompatibility preclinical tests with respect to ISO 10993 standards, and afterwards by clinical trials. Even though possible but rare side effects can occur, a plethora of literature evidence demonstrates that HA fillers have a favorable benefit/risk profile [ 23 , 26 , 27 ]. The incorporation of lidocaine was also already proven to not adversely affect the safety profile of soft-tissue fillers [ 1 , 12 ].…”

Section: Discussionmentioning

confidence: 99%

Comparative Preclinical Study of Lidocaine and Mepivacaine in Resilient Hyaluronic Acid Fillers

et al. 2022

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Background: Hyaluronic acid-based filler injections are now well-established aesthetic procedures for the correction of skin tissue defects and volume loss. Filler injections are becoming increasingly popular, with a growing number of injections performed each year. Although classified as a minimally invasive procedure, the introduction of a needle or a canula may remain painful for the patient. A major improvement was achieved with the incorporation of local anesthetics into the formulation for pain relief. Methods: In this study, two well-known anesthetics, lidocaine and mepivacaine, were systematically compared to assess their influence on filler mechanical and biological features. The impact of each anesthetic was monitored in terms of gel rheological properties, stability, durability, and degradation. The release profiles of each anesthetic were also recorded. Finally, the pharmacokinetics of each anesthetic in rats were assessed. Results: For all the rheological and biological experiments performed, lidocaine and mepivacaine influences were comparable. The addition of either anesthetic into a soft-tissue filler showed no significant modifications of the stability, durability, and degradability of the gel, with similar release profiles and pharmacokinetics at an equivalent concentration. Conclusions: Substituting lidocaine with mepivacaine does not impact the properties of the gels, and thus both can be equally incorporated as anesthetics in soft-tissue fillers.

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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

Cited by 2 publications

References 30 publications

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

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

Comparative Preclinical Study of Lidocaine and Mepivacaine in Resilient Hyaluronic Acid Fillers

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