Efficacy and Safety of 3 New Resilient Hyaluronic Acid Fillers, Crosslinked With Decreased BDDE, for the Treatment of Dynamic Wrinkles: Results of an 18-Month, Randomized Controlled Trial Versus Already Available Comparators

Abstract

BACKGROUND Three new hyaluronic acid (HA)-based fillers made of long chains crosslinked with reduced amounts of 1,4-butanediol diglycidyl ether (BDDE) were developed for the treatment of dynamic facial areas. Their resilience and increased stretching ability were optimized to ease injectors' practice and provide patients with most natural aesthetic results. OBJECTIVE This study aimed at evaluating the efficacy, durability, and safety of these resilient HA fillers versus commercially available comparator gels. METHODS A prospective, monocentric, split-face, double-blinded, randomized, controlled trial was performed on 90 subjects presenting moderate to severe bilateral nasolabial folds (NLFs). Efficacy parameters were assessed over 18 months, including improvement on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale, as well as quantitative imaging and analysis of NLF correction. Physicians' and subjects' satisfaction, together with safety, were assessed throughout the study. RESULTS The new HA fillers offered efficacy and safety profiles at least equivalent to comparators. These dynamic facial fillers elicited higher satisfaction immediately after injection but also on the long run, according to both investigators and subjects. CONCLUSION This pilot trial demonstrated the numerous benefits of 3 new resilient HA fillers with decreased BDDE crosslinking in the treatment of dynamic wrinkles.

Clinical Experience with PEGylated Hyaluronic Acid Fillers: A 3-year Retrospective Study

“…On the other hand, some tardive inflammatory phenomenon have been advocated to be related to BDDE concentration, in fact, some studies have tried to show an higher safety and biocompatibility of HA filler with decreased BDDE. Moreover, decreased BDDE has been advocate as capable of increase filler elasticity and get more natural results [9]. In 2014, in Europe, for the first time, a HA filler containing PEG as cross-linking agent was introduced in the market.…”

“…All these factors have contributed to BDDE becoming the industry-standard crosslinker [8]. However, recent studies about tardive inflammatory phenomenon following HA filler injection have pointed out the hypothesis that degradation of cross-linked HA filler may expose trace substances of BDDE that can induce inflammatory phenomenon characterized by tardive swelling or nodule development [9]. In the past years, a new cross-linking agent has been used in order to stabilize HA chains in HA filler industry: The poly (ethylene glycol) also known as PEG.…”

Using injectable fillers for midface rejuvenation

“…It is thought that these products (RHA 2, 3, 4) are able to adapt to facial movements to treat dynamic wrinkles and folds, a typical indication for neuromodulators [98] . Recently FDA approved for the correction of deep dynamic wrinkles, including the nasolabial folds; RHA 2 and 3 are indicated for injection into the mid-to-deep dermis, while RHA 4 is indicated for injection into the deep dermis to superficial subcutaneous tissue [99] . One split-face, randomized controlled trial on 90 subjects with moderate to severe nasolabial folds found at least equivalent efficacy and safety profiles with comparable fillers [100] .…”

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

“…Several published clinical trials have demonstrated the safety and tolerability of the range and have established the clinical effectiveness of specific formulations for various indications. 16,17,[19][20][21][22]…”