NCT02128204

The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: SciVision Biotech Inc. · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital Institutional Review Board. The aim of this post-marketing study is to evaluate the safety and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds. The study was estimated to be held half to one year including a 0-2 weeks screening period, a day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be obtained before volunteers enter screening period. If the volunteers meet all the criteria, they will be given a number to replace their name in the study. The participants will be randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment evaluated any recorded adverse events following the device treatments either by blinded evaluator or subjects. The effectiveness of the treatment devices will be assessed by using photographic assessment, nasoalabial folds severity scale, global aesthetic improvement scale, and pain visual analog scale.

Conditions

• Pain
• Nosalabial Folds Correction

Interventions

Type	Name	Description
DEVICE	lidocaine contained hyaluronate facial dermal filler	HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.
DEVICE	hyaluronate facial dermal filler	Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2015-01-01
• First posted: 2014-05-01
• Last updated: 2015-01-21

Locations

1 site across 1 country: Taiwan