Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation
Condition: Aging Problems
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 26 versus Juvederm Voluma™ after treatment of subcutaneous to
      upper-periostea tissue, or deep dermis implantation for cheek augmentation and age-related
      facial-volume deficit.
    

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 26 versus Juvederm Voluma™ after treatment of subcutaneous to
      upper-periostea tissue, or deep dermis implantation cheek augmentation and age-related
      facial-volume deficit.

      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 side of the midface will be treated with the investigational device and which side
      will be treated with the comparator device.

      The subjects will undergo baseline assessments of Medicis Midface Volume Scale (MMVS) 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, MMVS 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 midface side 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 14 days after the injection.
      Subjects receiving touch-up will attend an additional evaluation visit 1 month after touch-up
      (in addition to other visits).

      The treating investigators will complete a usability questionnaire.
    

Intervention name(s): DKL crosslinked sodium hyaluronate 26; Juvéderm Voluma™ with lidocaine (Allergan, Inc)
Intervention type(s): Device; Device
Intervention description(s): is injected into the midface on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 26 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.; is injected into the midface on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Voluma™ 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, non-inferiority study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Age related facial-volume deficit