At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Multicenter Study Evaluating Saypha® VOLUME Lidocaine* for the Correction of Nasolabial Fold
In Brief
A clinical study evaluating Saypha Volume Lidocaine for Moderate to Severe Nasolabial Folds. Completed, enrolled 110 participants across 3 sites.
Detailed Summary
Comparison of saypha Volume Lidocaine from 2 different manufacturing locations in correcting moderate to sever nasolabial folds
Study Details
Timeline
Interventions
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