Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance
Condition: Aging, Premature
MeSH terms: Aging, Premature
Study type: Interventional

Summary: 
      This is a pivotal, prospective active-controlled, randomized, double blinded (blinded
      evaluator and subject), intra-individual split-face comparison, non-inferiority study of DKL
      crosslinked sodium hyaluronate 23 versus Juvederm Volift™ after injection into the mid to
      deep dermis for correction of moderate to deep nasolabial folds (NLFs).
    

Detailed description: 
      This is a pivotal, prospective active-controlled, randomized, double blinded (blinded
      evaluator and subject), intra-individual split-face comparison, non- inferiority study of DKL
      crosslinked sodium hyaluronate 23 versus Juvederm Volift™ after injection into the mid to
      deep dermis for correction of moderate to deep nasolabial folds (NLFs).

      Approximately 40 subjects will be randomized and treated. Subjects will come to the research
      clinic for up to 6 visits, including a screening/baseline visit and up to 5 follow-up visits.

      At Screening eligible subjects (males and females aged 18 to 65 years) will be randomized as
      to which NLF will be treated with the investigational device and which NLF will be treated
      with the comparator device.

      The subjects will undergo baseline assessments of NLF Wrinkle Severity Rating Scale (WSRS) by
      the evaluating investigator and have baseline two-dimensional (2D) photos taken, prior to
      treatment with the investigational device and comparator.

      Treatment will be performed by an unblinded treating investigator. Following treatment, the
      subjects will complete a subject eDiary in which they will assess pre-defined treatment
      related events experienced during the first 14 days after the injection.

      Additional visits will take place 1, 3, 6 and 9 months after the treatment. During these
      visits the subjects will undergo evaluations by an evaluating investigator blinded to the
      treatment allocation. Assessments will include photography, NLF WSRS and Global Aesthetic
      Improvement Scale (GAIS). The subjects will also evaluate treatment outcome using the GAIS
      and complete a patient satisfaction questionnaire. The investigator will record any adverse
      events (AEs) that have occurred and will note their severity and relationship to the injected
      product.

      An optional touch-up treatment will be performed one month after the initial treatment at the
      discretion of the treating investigator. Subjects requiring touch-up will receive touch-up
      according to the original randomization scheme, i.e. the investigational device and
      comparator product will be injected to the same NLF according to the randomization scheme.
      Following touch-up, these subjects will be asked to complete a subject eDiary for assessment
      of pre-defined treatment related events experienced during the first 14 days after the
      injection. Subjects receiving touch-up will attend and additional evaluation visit one month
      after touch-up (in addition to other visits).

      The treating investigators will complete a usability questionnaire.
    

Intervention name(s): DKL crosslinked sodium hyaluronate 23; Juvéderm Volift™ with lidocaine (Allergan, Inc)
Intervention type(s): Device; Device
Intervention description(s): is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 23 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.; is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Volift™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
Intervention MeSH terms: Lidocaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premature skin aging; Correction of facial structural defects; Wrinkles