NCT04569045

Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds

A Randomized, Within-subject Controlled Clinical Study to Evaluate the Safety and Effectiveness of Pain Relief of Modified Sodium Hyaluronate Gel for Injection When Used for the Correction of Moderate or Severe Nasolabial Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: SciVision Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the safety and effectiveness of pain relief of modified sodium hyaluronate gel for injection when used for the correction of moderate or severe nasolabial folds.

Detailed description

One hundred and thirty patients were enrolled and there two sides of nasolabial folds (NLF) were randomized to receive HA with lidocaine or HA. The primary outcome was immediate visual analogue scale (VAS) of pain evaluated after injection for both NLF sides. Secondary outcomes including VAS pain, wrinkle severity rating scale (WSRS), global aesthetic improvement scale (GAIS) and AE were observed at 1, 3, 6, 9, 12 follow-ups.

Conditions

• Dermal Filler
• Hyaluronic Acid
• Lidocaine
• Nasolabial Fold

Interventions

Type	Name	Description
DEVICE	HA+Lidocaine	20 mg
DEVICE	HA	20 mg

Timeline

• Start date: 2020-08-20
• Primary completion: 2020-12-04
• Completion: 2021-12-10
• First posted: 2020-09-29
• Last updated: 2022-02-25

Locations

2 sites across 1 country: China