Plastic and Reconstructive Surgery, Global Open (Dec 2021)

Facial Skin Revitalization with Cohesive Polydensified Matrix-HA20G: Results from a Randomized Multicenter Clinical Study

  • Martina Kerscher, MD,
  • Welf Prager, MD,
  • Tanja C. Fischer, MD, PhD,
  • Gerd G. Gauglitz, MD,
  • Tatjana Pavicic, MD,
  • Ulrich Kühne, MD,
  • Maria Kravtsov, MSc,
  • Matthias Hofmann, PhD,
  • Hanna Dersch, MSc,
  • Sonja Sattler, MD

DOI
https://doi.org/10.1097/GOX.0000000000003973
Journal volume & issue
Vol. 9, no. 12
p. e3973

Abstract

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Background:. There is a growing interest in the application of hyaluronic acid (HA) derivatives in skin quality improvement. The aim of this study was to confirm safety and effectiveness of cohesive polydensified matrix-hyaluronic acid + glycerol (CPM-HA20G; Belotero Revive) in revitalization of early-onset photodamaged facial skin. Methods:. A total of 159 subjects with early signs of facial photodamaged skin were randomized in a 2:1 ratio to multiple- or single-dose treatment with CPMHA20G. Effectiveness assessments included biophysical measurements of skin hydration; elasticity, firmness, and roughness; investigator- and subject-assessed Global Aesthetic Improvement Scales; and FACE-Q Skin Changes and Treatment Satisfaction questionnaires. Results:. In both treatment groups, skin hydration improved from baseline to all follow-up visits in subjects with dry or very dry skin. This improvement was significant at week 16 after initial treatment in the multiple-dose group (P = 0.0013). Investigator- and subject-reported outcomes showed that the majority of subjects across all skin hydration types benefited from treatment, with higher satisfaction rates observed in the multiple-dose group. According to investigator-assessed Global Aesthetic Improvement Scale, 90.7% of subjects at week 12 in the multiple-dose and 74.6% of subjects at week 4 in the single-dose group were rated as at least “improved.” All related treatment-emergent adverse events were transient, expected injection-site reactions of mild to moderate intensity. Conclusions:. Effectiveness of CPM-HA20G for skin hydration in subjects with dry or very dry skin was demonstrated up to 9 months after last injection. Overall, CPM-HA20G demonstrated effective and safe use in facial skin revitalization among subjects with early-onset photodamaged skin.