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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
20 mg
20 mg
Beijing
Beijing, China
Shanghai
Shanghai, China
Immediate VAS pain evaluated after injection for both NLF sides
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Time frame: Immediate post-injection
VAS pain evaluated 15, 30, 45 and 60 minutes after injection for both NLF sides
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Time frame: 15, 30, 45 and 60 minutes post-injection
On-site WSRS evaluated by site blinded-evaluator at 1, 3, 6, 9 and 12 months
Evaluators assess the wrinkle severity of nasolabial folds on site or photographically with 5 graded scale,1 to 5 was represented 'absent' to 'extreme'.
Time frame: 1, 3, 6, 9 and 12 months post-injection
GAIS evaluated photographically by independent blinded-evaluator at 1, 3, 6, 9 and 12 months
Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.
Time frame: 1, 3, 6, 9 and 12 months post-injection
Adverse events reported from the baseline and during the study period
The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.
Time frame: 1, 3, 6, 9 and 12 months post-injection
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