Saypha® Volume LIdocaine in Nasolabial Folds

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

May 27, 2021

Study Completion Date

February 16, 2022

Conditions
Moderate to Severe Nasolabial Folds
Interventions
COMBINATION_PRODUCT

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"

Trial Locations (3)

1010

Yuvell, Vienna

1180

Ordination Dr. Gaerner, Vienna

Privatklinik Waehring GmbH, Vienna

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Croma-Pharma GmbH

INDUSTRY

NCT04883632 - Saypha® Volume LIdocaine in Nasolabial Folds | Biotech Hunter | Biotech Hunter