NCT04971876

Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

Prospective, Interventional, Non-Randomized, Open Label Study for the Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Hallura Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.

Conditions

• Lips Enhancement
• Nasolabial Fold Correction
• Midface Volume Deficit

Interventions

Type	Name	Description
DEVICE	HLR-1	Initial injection of HLR-1 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL.
DEVICE	HLR-2	Initial injection of HLR-2 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL per NLF.
DEVICE	HLR-3	Initial injection of HLR-3 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 4mL per cheek.

Timeline

• Start date: 2020-10-27
• Primary completion: 2022-08-11
• Completion: 2022-09-06
• First posted: 2021-07-22
• Last updated: 2022-11-03

Locations

3 sites across 2 countries: Germany, Poland