- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04622085
The Evaluation of the Safety and Effectiveness of ANIMERS Chiara LA and JUVÉDERM VOLUMA® for Aging Mid-Face
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ANIMERS Chiara LA
|
20mg/SciVision Biotech Inc.
|
Active Comparator: JUVÉDERM VOLUMA®
|
20mg/Allergan, Inc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS)
Time Frame: 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'. |
6 months post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.
Time Frame: 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.
|
Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
|
MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Time Frame: 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'.
|
Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
|
A Response rate of MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Time Frame: 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'. |
Immediate, 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.
Time Frame: 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'.
|
Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
|
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'.
|
Immediate,15, 30, 45 and 60 minutes post-injection
|
Adverse events reported during the study period
Time Frame: 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.
|
Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
|
Serious adverse events reported during the study period
Time Frame: 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.
|
Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
|
Device failure reported before injection
Time Frame: 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.
|
Before injection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RDCT-AHSK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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