110
Participants
Start Date
November 5, 2019
Primary Completion Date
May 27, 2021
Study Completion Date
February 16, 2022
Saypha Volume Lidocaine
"correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma.~The amount injected depended on the size of the area to be corrected and the desired level of soft tissue augmentation. It was estimated that a maximum volume of 4 mL per treatment was needed but should not have exceeded 10 mL in total per treatment or 20 mL per year. and use in respective indications. The investigational device was administered to eligible subjects on investigation Day 0. A touchup treatment at Week 2 was optional at the investigator's discretion if full correction was"
Yuvell, Vienna
Ordination Dr. Gaerner, Vienna
Privatklinik Waehring GmbH, Vienna
Lead Sponsor
Croma-Pharma GmbH
INDUSTRY