Evaluate the Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Filler in the Treatment of Nasolabial Folds.
Condition: Wrinkles Such as Nasolabial Folds
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of PavéDerm J-fill soft
      dermal filler vs. Restylane® Lyft lidocaine in the treatment of moderate to severe nasolabial
      folds.
    

Detailed description: 
      This is a single-center, subject and evaluator blinded, intra-individual, split-face
      controlled clinical trial. After subjects voluntarily give written consent to the
      participation in the study, his/her eligibility for the study will be judged through
      demographic and past & medication history investigation and laboratory test.

      Subjects eligible in the screening will be enrolled. Each patient will receive PavéDerm
      J-Fill Soft Dermal Filler in one nasolabial fold and Restylane Lyft Lidocaine (20 mg/mL
      Hyaluronic acid with 3 mg/ml Lidocaine hydrochloride) in the other by randomization.

      The faces of all subjects are going to be digitally photographed at rest upon every visit.
      The identical ambient conditions will be used for all photographs and assessments. To ensure
      blinding status, the subjects will be put on eye mask during injection. On injection day,
      subjects will receive injections, with at least 60 minute apart, to each nasolabial fold by
      the treating investigator. The amount of injection will be determined according to the width,
      length, and depth of the nasolabial folds to ensure optimal correction for each subject. The
      injected volume will not exceed 1.0 mL in ipsilateral nasolabial fold. The relevant
      information associated with the injection of the investigational medical device will be
      documented.

      After each injection, the treating investigator will observe subjects through 30 minutes for
      assessment of adverse events. Subjects will be asked about adverse events at each follow-up
      visit, and any adverse events will be documented for safety assessment.

      Clinical efficacy will be assessed by the appropriately trained evaluator using the WSRS and
      GAIS under blinded fashion, as well as by subjects using GAIS. Pre-treatment photographs of
      each subject taken at the pre-treatment (baseline) will be reviewed and will be used for
      comparison. The blinded evaluator will assess the photographs taken at each visit after the
      study device administration (photographic assessment). All subjects will perform the
      self-assessment by comparing their appearance in a mirror against a high-magniﬁcation
      photograph taken at baseline at each visit after the study device administration. The mirror
      symmetry will be reminded in all subjects. Under the explanation by the treating investigator
      or designee, subjects will assess the satisfaction of wrinkle improvement using the GAIS
      scoring.

      Pain is going to be assessed using a patient self-assessment 10-cm visual analogue scale with
      anchors at 0 m (no pain) and 10 cm (extreme pain).
    

Intervention name(s): PavéDerm J-Fill Soft Dermal Filler; Restylane® Lyft Lidocaine
Intervention type(s): Device; Device
Intervention description(s): Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL; Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other