RHA®4 for Midface Volume Deficiency

CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

October 29, 2021

Primary Completion Date

January 17, 2023

Study Completion Date

January 29, 2024

Conditions
Cheek AugmentationCorrection of Age-related Midface Contour Deficiencies
Interventions
DEVICE

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)."

DEVICE

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)."

Trial Locations (1)

02467

United States, Massachusetts, Chestnut Hill

All Listed Sponsors
lead

Teoxane SA

INDUSTRY

NCT05133739 - RHA®4 for Midface Volume Deficiency | Biotech Hunter | Biotech Hunter