title: Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study.
abstract: BACKGROUND
  Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft tissue defects.
  
  
  OBJECTIVE
  To compare the efficacy and safety of a novel HA filler, HA(E) (Emervel Deep), with those of HA(P) (Restylane Perlane) in the treatment of severe nasolabial folds (NLF).
  
  
  METHODS
  A split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive injection of HA(E) or HA(P) on their left or right NLF. Efficacy was evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Local tolerability was assessed based on subject diary during the first 3 weeks after injection. Adverse events were also evaluated.
  
  
  RESULTS
  At both weeks 12 and 24, the mean improvement in WSRS from baseline was significantly greater for HA(E) than for HA(P) (1.58±0.89 vs. 1.33±0.82 at week 24; P=0.002). Similar volume of both products was injected at baseline and touch-up. Both fillers were well tolerated, with similar worst score distribution and mean score for erythema, edema/swelling, bruising, and pruritus. Significantly less severe pain/tenderness was reported with HA(E) than with HA(P) (P<0.05).
  
  
  CONCLUSIONS
  The new HA filler HA(E) provides better efficacy and similar local tolerability compared with HA(P) 6 months after the treatment of severe NLF.
authors.affiliation: Clinique de Chirurgie Esthétique Iéna, 11 Rue Fresnel, Paris, France. benjaminascher@wanadoo.fr
authors.forename: Benjamin
authors.initials: B
authors.lastname: Ascher
authors.forename: Christiane
authors.initials: C
authors.lastname: Bayerl
authors.forename: Patrick
authors.initials: P
authors.lastname: Brun
authors.forename: Philippe
authors.initials: P
authors.lastname: Kestemont
authors.forename: Berthold
authors.initials: B
authors.lastname: Rzany
authors.forename: Michel
authors.initials: M
authors.lastname: Poncet
authors.forename: Mohammed
authors.initials: M
authors.lastname: Guennoun
authors.forename: Maurizio
authors.initials: M
authors.lastname: Podda
mesh_terms: D000328:Adult; D000368:Aged; D003357:Cosmetic Techniques / Q000009:adverse effects; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D015595:Skin Aging / Q000187:drug effects*
chemical_list: D006820:Hyaluronic Acid; C445361:Restylane