The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction

SciVision Biotech

Status

Completed

Conditions

Nosalabial Folds Correction

Pain

Treatments

Device: hyaluronate facial dermal filler

Device: lidocaine contained hyaluronate facial dermal filler

Study type

Interventional

Funder types

Industry

Identifiers

NCT02128204

RDCT-YDL

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

25 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures
Have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1
Agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections
Agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 months after the injections
If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures

Exclusion criteria

Have history or active dermal diseases, inflammation, or any related disease
Had permanent or semi-permanent implantation on nasolabial areas
Had invasive aesthetic treatments or surgeries history 6 months before the treatments
Had physical or chemical aesthetic treatments 1 months before the study starts
Have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments
Have Adams-Stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular
Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
Have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics
Have poor compliance with the study or follow-up schedule