Volume Deficit in the Mid-face Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Split-Face 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
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.
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. ;