The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face

The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face

This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group.

Study Overview

• Status: Completed
• Conditions: Lidocaine; Hyaluronic Acid; Dermal Filler; Aging Mid-Face
• Intervention / Treatment: Device: 2% HA

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 30 to 60 years of male or female
2. MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.

Exclusion Criteria:

1. Injection site with infection or other skin diseases present which may affect the evaluation
2. With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at midface
3. With permanent implants or planning to receive permanent implants during the study period at the injection sites
4. Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 6 months
5. 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
6. With Major surgery 3 months before the start of the trial
7. 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
8. 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.)
9. With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications
10. With epilepsy or porphyria
11. With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
12. With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
13. 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
14. 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
15. Pregnant, planning pregnancy or in breastfeeding females
16. 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 Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HA + Lidocaine	Device: 2% HA; 2% HA
No Intervention: Negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS).	The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.	The digital image scoring system analyzes the volume change (ml).	Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.	Evaluators assess the midface volume deficit scale on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.	Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.	The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.	Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.	Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.	Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection.	The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.	Immediate,15, 30, 45 and 60 minutes 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.	Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
Serious 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.	Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
Device failure 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.	Baseline

Collaborators and Investigators

• Sponsor: SciVision Biotech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): November 4, 2021
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RDCT-AHSK1

Drug and device information, study documents

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