50
Participants
Start Date
March 15, 2021
Primary Completion Date
August 17, 2021
Study Completion Date
November 29, 2021
Split-face injection of RHA® 4 with a cannula into a single NLF.
"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 NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~The brand of cannula used for injection is up to the discretion of the Treating Investigator (TI), providing the cannula is registered for use by the US FDA."
"Split-face injection of RHA® 4 with a needle (TSK 27G x ½) into the contralateral NLF."
"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 NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF)."
United States, North Carolina, Chapel Hill
United States, Florida, West Palm Beach
United States, Tennessee, Nashville
United States, California, Encinitas
Teoxane SA
INDUSTRY