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

NCT04569045 | Completed

• 1 other identifier: RDCT-CNFL
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Dermal Filler; Hyaluronic Acid; Lidocaine; Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• VAS pain evaluated 15, 30, 45 and 60 minutes after injection for both NLF sides

  15, 30, 45 and 60 minutes post-injection

• On-site WSRS evaluated by site blinded-evaluator at 1, 3, 6, 9 and 12 months

  1, 3, 6, 9 and 12 months post-injection

• GAIS evaluated photographically by independent blinded-evaluator at 1, 3, 6, 9 and 12 months

  1, 3, 6, 9 and 12 months post-injection

• Adverse events reported from the baseline and during the study period

  1, 3, 6, 9 and 12 months post-injection

Study Arms (2)

HA + Lidocaine

EXPERIMENTAL

Sodium Hyaluronate with Lidocaine Hydrochloride

Device: HA+Lidocaine

HA

ACTIVE COMPARATOR

Sodium Hyaluronate

Device: HA

Interventions

HA+Lidocaine DEVICE

20 mg

HA + Lidocaine

HA DEVICE

20 mg

HA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SciVision Biotech Inc.: lead

Study Sites (2)

Beijing

Beijing, China

Location

Shanghai

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject's two sides of nasolabial folds (NLF) were randomized to receive FACILLE® Light (contains Lidocaine) or FACILLE® (without Lidocaine).

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: August 20, 2020
• Primary Completion: December 4, 2020
• Study Completion: December 10, 2021
• Last Updated: February 25, 2022

Record last verified: 2021-02

Locations

CN (2)