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Completed

NCT Number: NCT04599335

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

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.

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Key information

Conditions

Dermal Filler Aging Mid-Face Hyaluronic Acid Lidocaine

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

2% HA

Device

2% HA

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SciVision Biotech Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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