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

Sponsor
SciVision Biotech Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04599335
Collaborator
(none)
80
1
2
29
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 2% HA
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face
Actual Study Start Date :
Dec 31, 2020
Actual Primary Completion Date :
Nov 4, 2021
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HA + Lidocaine

Device: 2% HA
2% HA

No Intervention: Negative

Outcome Measures

Primary Outcome Measures

  1. Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS). [6 months]

    The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.

Secondary Outcome Measures

  1. Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months. [Baseline, 1, 3, 6, 12, 18 and 24 months post-injection]

    The digital image scoring system analyzes the volume change (ml).

  2. On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. [Baseline, 1, 3, 6, 12, 18 and 24 months post-injection]

    Evaluators assess the midface volume deficit scale on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.

  3. A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. [Baseline, 1, 3, 6, 12, 18 and 24 months post-injection]

    The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.

  4. GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. [Baseline, 1, 3, 6, 12, 18 and 24 months post-injection]

    Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.

  5. VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection. [Immediate,15, 30, 45 and 60 minutes post-injection]

    The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.

  6. Adverse events reported from the baseline and during the study period [Baseline, 1, 3, 6, 12, 18 and 24 months post-injection]

    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.

  7. Serious adverse events reported from the baseline and during the study period [Baseline, 1, 3, 6, 12, 18 and 24 months post-injection]

    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.

  8. Device failure reported from the baseline and during the study period [Baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan

Sponsors and Collaborators

  • SciVision Biotech Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SciVision Biotech Inc.
ClinicalTrials.gov Identifier:
NCT04599335
Other Study ID Numbers:
  • RDCT-AHSK1
First Posted:
Oct 22, 2020
Last Update Posted:
Feb 25, 2022
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 25, 2022