201
Participants
Start Date
October 29, 2021
Primary Completion Date
January 17, 2023
Study Completion Date
January 29, 2024
injection of RHA®4 in Midface
"RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.~Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek)."
injection of Comparator Product in Midface
"Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.~Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek)."
United States, Massachusetts, Chestnut Hill
Teoxane SA
INDUSTRY