Abstract
BackgroundInjectables that behave similarly to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine. A range of fillers made of high molecular weight hyaluronic acid (HA) chains with low crosslinking have been specifically developed to complement facial dynamics.AimsThe efficacy and safety of one of these resilient HA fillers, and its noninferiority to an effective comparator available in the US, were tested in the treatment of dynamic wrinkles.MethodsA 15‐month, prospective, multicenter, controlled, randomized, double‐blind, within‐subject (split‐face) clinical trial was conducted on 140 subjects with moderate‐to‐severe nasolabial folds (NLF). Study endpoints included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators (BLE), subjects, and treating investigators (TI). Subject perception was evaluated with FACE‐Q and satisfaction scales.ResultsThe per‐protocol population included 88 subjects (92% women) of all Fitzpatrick phototypes, with a mean age of 57 years. WSRS improvement was significantly greater with the resilient HA than its comparator over 15 months, including at week 24 (primary endpoint), as rated by BLE and TI. Results demonstrated the noninferiority of the resilient HA filler to its comparator. Aesthetic improvement and subject satisfaction were durably high, with an overall trend toward higher scores for the resilient HA filler. Both treatments were safe and well tolerated.ConclusionThe resilient HA filler made of long chains lightly crosslinked is at least equivalent to a well‐established comparator for the correction of NLF in subjects of diverse skin phototypes.
Highlights
Injectables that behave to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine
RHA4 belongs to a new generation of hyaluronic acid (HA)‐based dermal fillers characterized by a crosslinking technology developed to preserve high molecular weight HA chains and decrease their butanediol diglycidyl ether (BDDE) crosslinking rate, conferring mechani‐ cal resilience and tissue biointegration to these gels.[10]
The clinical efficacy of RHA4 was assessed by testing its nonin‐ feriority to Lyft, a popular and effective dermal filler already com‐ mercially available in the US, which has been used in various trials as a reference treatment to investigate the clinical efficacy of other HA‐based fillers.[16]
Summary
This was a prospective, multicenter, controlled, randomized, dou‐ ble‐blind, within‐subject (split‐face) clinical trial to assess the nonin‐ feriority of RHA4 vs Lyft for the correction of moderate‐to‐severe NLF (ClinicalTrials.gov Identifier: NCT02253147). The sensitivity analysis, which included all subjects who initiated treatment (ITT population), confirmed both the non‐ inferiority and superiority at week 24, with a mean difference be‐ tween WSRS scores of −0.22 (95% CI −0.34, −0.11). These results mirrored WSRS assessment by treating investigators, which reported. Analysis of the ITT population con‐ firmed a significantly (P = .002) greater WSRS responder rate for RHA4 (97.2%) than Lyft (87.9%) at week 24 (BLE ratings) These results mirrored the 1‐point WSRS responder rate assessment by treating investigators, which showed a lasting trend toward higher scores with RHA4 than Lyft throughout the study, reaching sta‐ tistical significance at weeks 2, 24, 36, and 52 (Figure 4D).
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