The Evaluation of the Safety and Effectiveness of ANIMERS Chiara LA and JUVÉDERM VOLUMA® for Aging Mid-Face
- Conditions
- Hyaluronic AcidLidocaineDermal FillerAging Mid-Face
- Interventions
- Device: ANIMERS Chiara LADevice: JUVÉDERM VOLUMA®
- Registration Number
- NCT04622085
- Lead Sponsor
- SciVision Biotech Inc.
- Brief Summary
This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the active control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Age 30 to 60 years of male or female
- MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ANIMERS Chiara LA ANIMERS Chiara LA - JUVÉDERM VOLUMA® JUVÉDERM VOLUMA® -
- Primary Outcome Measures
Name Time Method Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) 6 months post-injection The response rate is ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator at 6 months.
Evaluators assess the midface volume deficit scale (MFVDS) on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.
- Secondary Outcome Measures
Name Time Method MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. Immediate, 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'.
A Response rate of MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. Immediate, 1, 3, 6, 12, 18 and 24 months post-injection The response rate is ≥ 1 Grade improvement on the assessment of the MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Evaluators assess the midface volume deficit scale (MFVDS) on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. Immediate, 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'.
Adverse events reported during the study period Immediate, 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.
Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months. Immediate, 1, 3, 6, 12, 18 and 24 months post-injection The digital image scoring system analyzes the volume change (ml). A higher score means more volume increased in the midface.
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'.
Serious adverse events reported during the study period Immediate, 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.
Device failure reported before injection Before 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.
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan