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.

Background:Patient-reported outcomes are important measures when assessing the efficacy of aesthetic procedures.Objective:To compare outcomes between 2 volumizing hyaluronic acid fillers.Materials and Methods:Subjects with moderate-to-severe volume loss in the cheeks were randomized in a split-face design to malar enhancement with Cohesive Polydensified Matrix 26 mg/ml HA (CPM-26) and Vycross 20 mg/ml HA (VYC-20). The same injection technique and injection volume were applied for both sides of the face. Anesthetics, overcorrection, and touch-ups were not permitted. Blinded subjects assessed aesthetic improvements using the Global Aesthetic Improvement Scale and treatment satisfaction by confirming their willingness to repeat treatment or recommend it to friends. Follow-up was 18 months.Results:A total of 45 subjects received a single 2 mL injection of CPM-26 on one side and VYC-20 on the contralateral side of the face. The proportion of subjects reporting improvement on the Global Aesthetic Improvement Scale compared with baseline for CPM-26 and VYC-20 was 97.7% and 88.6%, respectively, at 3 months, 73.8% and 71.1% at 12 months, and 61.0% and 56.7% at 18 months. Treatment satisfaction was high, with the majority of subjects stating that they would repeat treatment and recommend it to friends, but at each time point, a higher proportion of subjects was more satisfied with the CPM-26-treated side of the face.Conclusions:In this first direct comparison of CPM-26 and VYC-20, the majority of subjects were satisfied with both treatments throughout the study. Patient-reported outcome measures identified a trend in favor of CPM-26.