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

SciVision Biotech Inc.2 sites in 1 country130 target enrollmentAugust 20, 2020

ConditionsDermal Filler Hyaluronic Acid Lidocaine Nasolabial Fold

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dermal Filler
Sponsor: SciVision Biotech Inc.
Enrollment: 130
Locations: 2
Primary Endpoint: Immediate VAS pain evaluated after injection for both NLF sides
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 20, 2020

End Date

December 10, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SciVision Biotech Inc.

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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)
Adverse events reported from the baseline and 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(15, 30, 45 and 60 minutes 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)