A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment
Condition: Volume Deficit in the Mid-face
MeSH terms: Lipodystrophy
Study type: Interventional

Summary: 
      To compare the safety and efficacy profiles of Revanesse Shape + with Lidocaine versus
      Juvederm Voluma with Lidocaine for subcutaneous and/or supraperiosteal injection to improve
      appearance through the correction of age-related mid-face volume deficit in patients 22 years
      of age through 65 years of age.

      Midface volume deficit / lipoatrophy (loss of subcutaneous adipose tissue that is most
      apparent in the face) may be associated with acquired conditions, the aging process, or based
      on genetic causes.
    

Detailed description: 
      This is a randomized, multicenter, double blind, split-face study in subjects seeking to
      correct mid-face volume deficit. Subjects will be treated with Revanesse Shape + with
      Lidocaine on one side of the face and Juvederm Voluma with Lidocaine on the other side of the
      face. The side of the face for each device will be randomly assigned. The Evaluating
      Investigator performing the evaluations and the subject will be blinded to the treatment;
      injections of the study device will be performed by an unblinded Treating Investigator.

      At each visit, the blinded Evaluating Investigator evaluations and subject evaluations of the
      treated areas will be performed and recorded.

      The initial treatment will be done at Visit 1 and a touch-up if necessary at Visit 3/Month 1.
      One optimal correction touch-up can be administered for subjects who experience asymmetrical
      cheeks after Visit 5/Month 3 and before Visit 7/Month 12 . The Blinded Evaluating
      Investigator will confirm the asymmetry with at least a 1-grade difference between cheeks.
      The touch up will be offered on the under-corrected side with the same product that was
      initially implanted. In addition, subjects will have a safety follow-up telephone call 3 days
      (± 2 days) after any optimal correction touch-up to correct asymmetry administered between
      Visit 5/Month 3 and Visit 7/Month 12.

      Subjects will be retreated at the Month 12 Visit if a ≥ 1 grade change or return to baseline
      of the MMVS scores on one or both sides of the face.

      Treatment Phase

        -  Visit 1 - (Day 1) - Baseline and treatment

        -  Day 3 (+2/-1 days) - Safety follow-up telephone call

        -  Visit 2 - Week 2 (Day 14 ± 2 days) - Safety follow-up visit

        -  Visit 3 - Month 1 (Day 30 ± 2 days) - interim visit, optimal correction touch-up if
           needed

        -  If touch up administered at Visit 3:

        -  Safety follow-up telephone call 3 days after touch-up (± 2 days)

        -  Visit 3a - Day 14 ± 2 days after touch-up - Safety follow-up visit Safety and
           Effectiveness Phase

        -  Visit 4 - Month 2 (Day 60 ± 2 days) - interim visit

        -  Visit 5 - Month 3 (Day 90 ± 2 days) - interim visit

        -  Visit 6 - Month 6 (Day 180 ± 4 days) - interim visit Extended Follow-up Phase

        -  Visit 7 - Month 12 (Day 360 ± 4 days) - interim visit Retreatment if needed

        -  If Retreatment administered at Visit 7:

        -  Safety follow-up telephone call 3 days after retreatment (± 2 days)

        -  Visit 7a - Day 14 ± 2 days after retreatment - Safety follow-up visit

        -  Visit 8 - Month 15 (Day 450 ± 4 days) - End of Study Visit Optimal Correction Touch-up
           to correct asymmetry

        -  Visit 6a - After Visit 5/Month 3 and before Visit 7/Month 12) - optimal correction
           touch-up to correct asymmetry

        -  3 days after touch-up (± 2 days) - Safety follow-up telephone call

      Evaluations include:

      Medicis Mid-face Volume Scale (MMVS) score Global Aesthetic Improvement Score (GAIS) by
      subject and Evaluating Investigator Nasolabial Folds Wrinkle Severity Rating Score (WSRS)
      Safety will be assessed by monitoring adverse events (AEs) at all study visits. In addition,
      other mid-face safety evaluations including firmness, function (movement), mass formation and
      sensation will be performed at baseline and follow up visits.

      Other evaluations include subject overall satisfaction of facial appearance, subject
      satisfaction with mid-facial region, subject look of mid-face, subject feel of mid-face,
      subject self-perception of age, subject happiness with contour/shape of mid-face, subject
      self confidence, subject recommendation to a friend, and subject self perception of age since
      baseline.

      Other analysis includes subject comfort and Unblinded Treating Investigator Ease of Use
      assessment.
    

Intervention name(s): Revanesse Shape + with Lidocaine; Juvederm Voluma with Lidocaine.
Intervention type(s): Device; Device
Intervention description(s): Revanesse Shape + with Lidocaine. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine; Juvederm Voluma with Lidocaine. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A split-face study in subjects seeking to correct mid-face volume deficit. Subjects will be treated with Revanesse Shape + with Lidocaine on one side of the face and Juvederm Voluma with Lidocaine on the other side of the face. The side of the face for each device will be randomly assigned.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment