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

NCT04599335 | Completed

• 1 other identifier: RDCT-AHSK1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection.

  Immediate,15, 30, 45 and 60 minutes post-injection

Study Arms (2)

HA + Lidocaine

EXPERIMENTAL

Device: 2% HA

Negative

NO INTERVENTION

Interventions

2% HA DEVICE

2% HA

HA + Lidocaine

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• SciVision Biotech Inc.: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 22, 2020
• Study Start: April 6, 2021
• Primary Completion: November 4, 2021
• Study Completion: May 9, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

TW (1)