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

Lidocaine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599335
• Other study ID #: RDCT-AHSK1
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: May 9, 2023

Study information

• Verified date: October 2023
• Source: SciVision Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 9, 2023
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Mid-Face
• Dermal Filler
• Hyaluronic Acid
• Lidocaine

Intervention

Device:
• 2% HA
2% HA

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
SciVision Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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