Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569045
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
SciVision Biotech Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dermal Filler Hyaluronic Acid Lidocaine Nasolabial Fold Device: HA+Lidocaine Device: HA Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subject's two sides of nasolabial folds (NLF) were randomized to receive FACILLE® Light (contains Lidocaine) or FACILLE® (without Lidocaine).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 20, 2020
Actual Primary Completion Date : December 4, 2020
Actual Study Completion Date : December 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immediate VAS pain evaluated after injection for both NLF sides [ Time Frame: Immediate post-injection ]
    The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.


Secondary Outcome Measures :
  1. VAS pain evaluated 15, 30, 45 and 60 minutes after injection for both NLF sides [ Time Frame: 15, 30, 45 and 60 minutes post-injection ]
    The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.

  2. On-site WSRS evaluated by site blinded-evaluator at 1, 3, 6, 9 and 12 months [ Time Frame: 1, 3, 6, 9 and 12 months post-injection ]
    Evaluators assess the wrinkle severity of nasolabial folds on site or photographically with 5 graded scale,1 to 5 was represented 'absent' to 'extreme'.

  3. GAIS evaluated photographically by independent blinded-evaluator at 1, 3, 6, 9 and 12 months [ Time Frame: 1, 3, 6, 9 and 12 months post-injection ]
    Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.

  4. Adverse events reported from the baseline and during the study period [ Time Frame: 1, 3, 6, 9 and 12 months post-injection ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569045


Locations
Layout table for location information
China
Beijing
Beijing, China
Shanghai
Shanghai, China
Sponsors and Collaborators
SciVision Biotech Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: SciVision Biotech Inc.
ClinicalTrials.gov Identifier: NCT04569045    
Other Study ID Numbers: RDCT-CNFL
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action