Clinical trial NCT04599335: The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face
Official title: The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermal Filler
Hyaluronic Acid
Lidocaine
Aging Mid-Face
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS).
timeFrame: 6 months
Secondary outcomes:
measure: Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.
timeFrame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
measure: On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
timeFrame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
measure: A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
timeFrame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
measure: GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
timeFrame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
measure: VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection.
timeFrame: Immediate,15, 30, 45 and 60 minutes post-injection
measure: Adverse events reported from the baseline and during the study period
timeFrame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
measure: Serious adverse events reported from the baseline and during the study period
timeFrame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
measure: Device failure reported from the baseline and during the study period
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
References: