Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study

Abstract

BackgroundEnhancement of the midface can be achieved with volumizing hyaluronic acid (HA) fillers.ObjectiveThe objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix® 26 mg/mL HA gel (CPM-26) and Vycross® 20 mg/ml HA gel (VYC-20) in a controlled, randomized, evaluator-blind, split-face clinical study.Patients and methodsSubjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS) received CPM-26 on one side and VYC-20 on the contralateral side of the face. Effectiveness assessments were performed by blinded evaluators including photographic and live MAS ratings and live Global Aesthetic Improvement Scale (GAIS) ratings. Calculations of anatomical volume variations at month 3 (M3), month 6 (M6), month 12 (M12) and month 18 (M18) were also performed.ResultsNon-inferiority of CPM-26 versus VYC-20 was demonstrated at M3 (primary end point) based on MAS. GAIS rating showed that significantly more subjects had better improvement with CPM-26 than with VYC-20 at month 1, M3, M12 and M18 (p=0.0032, p=0.0074, p=0.0384 and p=0.0110, respectively). Standardized evaluation of volume variations from baseline to M3, M12 and M18 showed that CPM-26 created more volume augmentation at all time points, and the difference was significant at M3.ConclusionCPM-26 was non-inferior to VYC-20 based on MAS ratings at M3 and demonstrated a favorable safety and effectiveness profile for midfacial volume enhancement with results lasting up to M18.

A multi‐center, open‐label, pilot study of allograft adipose matrix for the correction of atrophic temples

“…The duration of effects for hyaluronic acid fillers has been reported at 3 to 12 months, 1 year,18 months, and 2 years . A recent study of the use of injectable hyaluronic acid gel to correct volume loss of facial temporal fossa showed that the effects of the gel persisted at least 12 months in 98% of subjects .…”

Patient-Reported Outcomes following Split-Face Injection of 2 Volumizing Fillers in the Upper Cheeks

“…The current study presented the patient-reported outcomes data from a single-center, randomized, controlled, split-face study that was also designed to evaluate the effectiveness and safety of CPM-26 compared with VYC-20. 13 , 14 The results of live assessment using the Merz Aesthetics Scale showed optimal correction for both products at visit M3 and longevity of the aesthetic effect up to M18. 14 Both products were also well tolerated.…”

“…According to the results of the blinded evaluator, 14 a volumizing effect was still present in more than half of the subjects with both products at M18, illustrating the longevity of the products. Based on MAS and GAIS ratings by the blinded evaluator and 3D volume assessment, CPM-26 showed a better performance.…”

“…Blinded physician evaluation of subjects using GAIS scoring is reported in a separate article 14 and demonstrated that at M18, 77.8% of CPM-26 cheeks and 64.5% of VYC-20 cheeks continued to show improvement compared with baseline (grade ≥ 1). In the current article, subjects were more critical in their GAIS scoring than the blinded physician evaluator, but overall results supported the conclusion of a high rate of improvement with both products, but with an overall trend in favor of CPM-26.…”

“…This single-center, randomized, controlled, split-face study was conducted from June 2013 to March 2015.The study design and methods have been described elsewhere. 13 , 14 Briefly, the study enrolled men or women aged ≥ 18 to ≤ 65 years presenting with bilateral, symmetrical, moderate-to-severe sunken upper cheeks (Merz Aesthetics Scale grade 2 and 3), seeking volume enhancement. 13 , 14 Subjects could not have been injected with permanent or semi-permanent fillers or have received any HA filler injection in the face for 2 years before study injection.…”