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

NCT ID: NCT04599335

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2023-05-09

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HA + Lidocaine

Group Type: EXPERIMENTAL

2% HA

Intervention Type: DEVICE

2% HA

Negative

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

2% HA

2% HA

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SciVision Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

RDCT-AHSK1

Identifier Type: -

Identifier Source: org_study_id