NCT03319719

Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs. Identify and describe adverse events (AEs) and serious adverse events (SAEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.

Conditions

• Correction of Moderate to Severe Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	Belotero® Balance with integral lidocaine	Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.
DEVICE	Belotero® Balance	Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.

Timeline

• Start date: 2017-09-18
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2017-10-24
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study