The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are: * The differences of Wrinkle Severity Rating Scale (WSRS) after the injection. * The differences of Global Aesthetic Improvement Scale (GAIS) after the injection. * The subjective satisfaction of treatment. * Safety Indicators of which incidences on the day of the injection or after the injection. Participants will be self-controlled and randomized for same period * received both trial product and control product at the same time. * re-visited on week 2, 4, 12, 24, 36, and 52 after injection. Researchers will compare if the test product is non-inferiority to Q-Med Restylane.
The purpose of this study is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. A single-centre, non-inferior, randomized, double-blind trial with a control group was conducted in this study. Every subject received the trial product and control product injections at the same time. It was planned to recruit 95 subjects with the 10% dropout rate. This clinical trial is accordance with the "Good Clinical Practice (GCP) issued by the Department of Health and ISO14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General Requirements and carried out according to the trial proposal approved by the Tri-Service General Hospital Human Subjects Review Committee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
98
Dermal filler injection to facial areas
Dermal filler injection to facial areas
WSRS improvement ratio at week 24 post-injection
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.
Time frame: Baseline and week 24
Difference of WSRS score
Based on the photographs, blinded physician rated the score of WSRS (Wrinkle Severity Rating Scales) for both group respectively. The WSRS is a 5-grade instrument for facial wrinkle, Grade 1(absent, no visible nasolabial fold; continuous skin line ) to Grade 5(extreme, extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone) And the difference of WSRS score was calculated as week 2, 4, 12 and 24 subtracted from baseline.
Time frame: Baseline to week 24 post-injection
GAIS score
Compared with the baseline photographs, blinded physician rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group respectively. And the difference of GAIS score was assessed at week 2, 4, 12 and 24.
Time frame: Baseline to week 24 post-injection
Difference of Satisfaction of treatment
Subjects rated the points of satisfaction after treatment subjectively from 1(extremely dissatisfied) to 5(extremely satisfied). And the difference of satisfaction was calculated as week 2, 4, 12 and 24 subtracted from baseline.
Time frame: Baseline to week 24 post-injection
Incidence of Treatment-related Adverse Events
The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.
Time frame: week 0 to week 52
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