title: A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvéderm® VOLUMA® with Lidocaine in mid-face area.
abstract: BACKGROUND
  Juvéderm® VOLUMA® with Lidocaine is a hyaluronic acid (HA)-based injectable gel that is used to restore the volume of the face. This study was designed to assess the real-world effectiveness of this HA gel over 21 days when used for mid-face augmentation in normal, healthy subjects desiring aesthetic improvement.
  
  
  METHODS
  This prospective, observational, single-arm, open-label post-marketing study enrolled 115 healthy subjects, from five European centers. The primary objective was to evaluate subject-reported satisfaction and experience of the treatment across a range of doses of Juvéderm® VOLUMA® with Lidocaine (1 ml/2 ml/combination), immediately after injection and 21 days post-treatment.
  
  
  RESULTS
  Subject satisfaction questionnaire (SSQ) scores of Delighted or Happy were given by 95.6% of subjects immediately after injection, and by 93.7% of subjects at Day 21. Overall, subject and investigator satisfaction with cosmetic effect and smoothness was very positive. Pain was minimal; most subjects experienced only minor degrees of discomfort, and this was mainly related to the procedure itself.
  
  
  CONCLUSIONS
  Juvéderm® VOLUMA® with Lidocaine was well accepted by both subjects and investigators, associated with high levels of satisfaction, was considered smooth and easy to use, and was well tolerated when used for the treatment of mid-face area volume enhancement.
authors.affiliation: Hautzentrum Köln (Cologne Dermatology) , Cologne , Germany.
authors.forename: Wolfgang G
authors.initials: WG
authors.lastname: Philipp-Dormston
authors.forename: David
authors.initials: D
authors.lastname: Eccleston
authors.forename: Koenraad
authors.initials: K
authors.lastname: De Boulle
authors.forename: Said
authors.initials: S
authors.lastname: Hilton
authors.forename: Helga
authors.initials: H
authors.lastname: van den Elzen
authors.forename: Myooran
authors.initials: M
authors.lastname: Nathan
mesh_terms: D000328:Adult; D000368:Aged; D004338:Drug Combinations; D004954:Esthetics; D005145:Face; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007267:Injections / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D017060:Patient Satisfaction; D011446:Prospective Studies; D015595:Skin Aging; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D004338:Drug Combinations; D005782:Gels; C000596435:Juvederm VOLUMA; D006820:Hyaluronic Acid
keywords: Juvéderm; VOLUMA; dermal filler; hyaluronic acid; mid-face area; volumizing