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

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.

Study Overview

• Status: Completed
• Conditions: Lidocaine; Nasolabial Fold; Hyaluronic Acid; Dermal Filler
• Intervention / Treatment: Device: HA+Lidocaine; Device: HA

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • BEIJING
  • Shanghai, China
    • Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 65 years of male or female
• Wrinkle Severity Rating Scale (WSRS) of bilateral nasolabial folds graded 3 or 4 by blinded evaluator (moderate to severe bilateral nasolabial fold), consistent grade of bilateral nasolabial folds, and the grades approved by the physician who perform the treatment
• Agree not to undergo any other under-eye facial surgery (including nose) during the study period

Exclusion Criteria:

• Injection site with infection or other skin diseases present which may affect the evaluation
• With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at nasolabial folds
• With permanent implants or planning to receive permanent implants during the study period at the injection sites
• Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 12 months
• With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
• With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period
• With prescription medication for nasolabial fold treatment, topical corticosteroid, skinirritating topical products or pigmentation products within the past 2 weeks or planning to take these medication or products during the study period
• With systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.)
• Severe liver or kidney defects (such as the value of ALT or AST over 1.5 folds of upper limit of normal value; the value of creatinine over 1.5 folds of upper limit of normal value)
• With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis removement medications
• With epilepsy or porphyria
• With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
• With the need to take b-blocker during the study period
• With severe atrioventricular block (type 2 second-degree AV block and third-degree AV block)
• With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
• With orthodontics, tooth extraction, tooth implantation (extraction or implantation of tooth anterior to the second premolar) or planning to receive these procedures during the study
• With history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; Gram-positive bacterial or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study
• Planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change
• Pregnant, planning pregnancy or in breastfeeding females
• With syphilis or HIV infection
• Participated in clinical study of other device or drug and have not terminated within the past 30 days -Other circumstances which judged to be unsuitable for participating in the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HA + Lidocaine; Sodium Hyaluronate with Lidocaine Hydrochloride	Device: HA+Lidocaine; 20 mg
ACTIVE_COMPARATOR: HA; Sodium Hyaluronate	Device: HA; 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	Immediate post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 3, 6, 9 and 12 months 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'.	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'.	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'.	1, 3, 6, 9 and 12 months post-injection

Collaborators and Investigators

• Sponsor: SciVision Biotech Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2020
• Primary Completion (ACTUAL): December 4, 2020
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (ACTUAL): September 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: RDCT-CNFL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No