Efficacy and tolerability of a new monophasic, double-crosslinked hyaluronic acid filler for correction of deep lines and wrinkles

J Drugs Dermatol. 2011 Feb;10(2):134-9.

Abstract

Background: A monophasic, highly crosslinked hyaluronic acid dermal filler offers further treatment options for deep lines.

Objective: To investigate the efficacy and tolerability of Belotero.

Methods and materials: A total of 149 patients received injections. Efficacy was assessed on the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Adverse events were recorded at each evaluation session.

Results: Mean WSRS improved significantly (P<0.001) by 1.9 score points without any decline throughout the 12-week period. Improvement was found in 89.9 percent of patients on the (GAIS), 59.7 percent of whom were designated as very much/much improved. Investigator and patient satisfaction was stated in more than 90 percent of cases as excellent/good. Adverse events, exclusively localized to the injection area, occurred in 85.9 percent of patients immediately after injection and declined to 12.8 percent in week 2. None were serious.

Conclusion: The findings indicate the benefit of the highly cross-linked, monophasic hyaluronic acid dermal filler, especially in the treatment of patients with deep and extremely deep folds. Overall, the filler appears to be well tolerated. This evaluation raised no major safety concerns.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Biocompatible Materials / administration & dosage*
  • Biocompatible Materials / adverse effects*
  • Biocompatible Materials / chemistry
  • Female
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Hyaluronic Acid / adverse effects*
  • Hyaluronic Acid / chemistry
  • Injections, Intradermal
  • Male
  • Middle Aged
  • Skin Aging*
  • Treatment Outcome

Substances

  • Biocompatible Materials
  • Hyaluronic Acid