NCT04883632

Saypha® Volume LIdocaine in Nasolabial Folds

A Prospective, Randomized, Multicenter Study Evaluating Saypha® VOLUME Lidocaine* for the Correction of Nasolabial Fold

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of saypha Volume Lidocaine from 2 different manufacturing locations in correcting moderate to sever nasolabial folds

Detailed description

Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be randomized to receive saypha® VOLUME Lidocaine from 1 of 2 manufacturing sites. The device will be injected into the deep dermis or supraperiostal, and subjects will return for follow-up assessments at Week 2, 4, 24, 36, 52 and optional at Week 65, 78 and 104 after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 4, 24, 36, 52 after the treatment and optional at Week 65, 78 and 104 and in comparison to Day 0. Telephone visits will be performed approximately 24 hours post-administration to monitor possible adverse events. In case any adverse events are reported during the telephone visits an unscheduled visit should be performed.

Conditions

• Moderate to Severe Nasolabial Folds

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-05
• Primary completion: 2021-05-27
• Completion: 2022-02-16
• First posted: 2021-05-12
• Last updated: 2025-04-03
• Results posted: 2025-04-03

Locations

3 sites across 1 country: Austria