title: Clinical and instrumental evaluation of a cross-linked hyaluronic acid filler dermal injection: effects on nasolabial folds skin biophysical parameters and augmentation from a single-dose, monocentric, open-label trial.
abstract: BACKGROUND
  When a hyaluronic acid dermal device to fill soft tissues is chosen, efficacy, safety and durability are key concerns. This is an open-label prospective study to instrumentally evaluate the effects of HA filler dermal injection on nasolabial folds skin biophysical parameters and augmentation.
  
  
  METHODS
  A single Italian site treated female subjects aged 40-55, for nasolabial folds, with a single standardized injection. The outcome was evaluated with objective quantitative measurements after 90 (T1) and 180 days (T2) from the injection comparing to baseline (T0) by means of Corneometer (skin hydration measurement), Cutometer (skin elasticity measurement), and Visioface devices for digital and UV computerized image analysis. Secondary endpoints were safety assessment, subject investigator satisfaction with the intervention. Assessment of aesthetic results included photographic documentation.
  
  
  RESULTS
  The computerized image analysis confirmed the clinical assessment showing statistically significant reduction in nasolabial folds both at T1 and T2. Visioface® indexes showed a marked and statistical significant response. An excellent profile of satisfaction of the product at T2 from investigators and patients was recorded. Skin hydration and elasticity did not show significant changes.
  
  
  CONCLUSIONS
  In our study, a standardized HA filler dermal injection on nasolabial folds did not influence skin biophysical parameters such as skin hydration and elasticity. Nasolabial folds showed a persistent and significative response at T2 confirmed by instrumental evaluation. The tolerability and safety profile of the product was excellent.
authors.affiliation: Department of Dermatology, San Gallicano Institute IRCCS, Rome, Italy - cameli@ifo.it.
authors.forename: Norma
authors.initials: N
authors.lastname: Cameli
authors.forename: Maria
authors.initials: M
authors.lastname: Mariano
authors.forename: Mirko
authors.initials: M
authors.lastname: Serio
authors.forename: Enzo
authors.initials: E
authors.lastname: Berardesca
mesh_terms: D000328:Adult; D003357:Cosmetic Techniques / Q000009:adverse effects; D000067548:Dermal Fillers / Q000008:administration & dosage* / Q000009:adverse effects; D004548:Elasticity; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007271:Injections, Intradermal; D008875:Middle Aged; D060052:Nasolabial Fold; D017060:Patient Satisfaction; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000067548:Dermal Fillers; D006820:Hyaluronic Acid